Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04582669
Status:
TERMINATED
Last Update Posted:
2023-11-13
First Post:
2020-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}], 'ancestors': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hheibel@montefiore.org', 'phone': '(718) 920-8352', 'title': 'Haley Heibel, MD', 'organization': 'Montefiore Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'OG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'timeFrame': 'Baseline, Days 2, 6, 14, and 28', 'description': 'Numeric Rating Scale is a pain scale scored with whole integers from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable". Higher score indicates worse pain.', 'reportingStatus': 'POSTED', 'populationDescription': 'NRS scoring data was not collected and aggregated and/or analyzed at any of the identified timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HS-PGA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'OG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'timeFrame': 'Baseline and Week 4', 'description': 'HS-PGA is a six-staged physician global assessment tool (score ranges from 0 to 5) based on number of HS lesions including inflammatory and/or non-inflammatory nodules, abscesses, and draining fistulas. Higher HS-PGA score indicates more severe HS disease.', 'reportingStatus': 'POSTED', 'populationDescription': 'HS-PGA scoring data was not collected and aggregated and/or analyzed at any of the identified timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'OG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'timeFrame': 'Baseline and Week 4', 'description': 'CRP (measured in mg/dL) is an inflammatory marker. A higher value is correlated with more severe disease.', 'reportingStatus': 'POSTED', 'populationDescription': 'CRP data was not collected and aggregated and/or analyzed at any of the identified timepoints. Laboratory analyses were not conducted.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hidradenitis Suppurativa (HS) Lesion Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'OG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'timeFrame': 'Baseline and Week 4', 'description': 'HS lesion size will be measured using a metric ruler in centimeters. Measurement will be standardized according to greatest diameter as lesions will be measured from edge of one border to the edge of the opposite border.', 'reportingStatus': 'POSTED', 'populationDescription': 'HS lesion size data was not collected and aggregated and/or analyzed at any of the identified timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'OG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'timeFrame': 'Baseline, Days 2, 6, 14, and 28', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered outcome measures that assesses physical, mental, and psychosocial health in adults and children. Clinical measures of health outcome includes physical function, mobility, pain, fatigue, emotional stress, ability to participate in social roles, sleep-related impairment, depressive symptoms/sadness, anxiety/fear, and anger. The scores are rated on a scale from 0 to 100 with "0" being "best functioning" and "100" being "worst functioning".', 'reportingStatus': 'POSTED', 'populationDescription': 'PROMIS data was not collected/aggregated and therefore not analyzed at any of the identified timepoints.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'OG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': "Evaluate the morphologic changes in participant's skin from baseline, specifically assessing\n\n1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris\n2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.\n3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'OG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 2', 'description': "Evaluate the morphologic changes in participant's skin from baseline, specifically assessing\n\n1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris\n2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.\n3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were two fewer subjects than baseline because subject(s) did not present for visit and/or meet eligibility criteria, and data was not collected and/or analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'OG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 6', 'description': "Evaluate the morphologic changes in participant's skin from baseline, specifically assessing\n\n1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris\n2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.\n3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There was one fewer subject than baseline because subject did not meet eligibility criteria, and data was not collected and/or analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'OG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': "Evaluate the morphologic changes in participant's skin from baseline, specifically assessing\n\n1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris\n2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.\n3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were four fewer subjects than baseline because subject(s) did not present for visit and/or meet eligibility criteria, and data was not collected and/or analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'OG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'description': "Evaluate the morphologic changes in participant's skin from baseline, specifically assessing\n\n1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris\n2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.\n3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were six fewer subjects than baseline because subject(s) did not present for visit and/or meet eligibility criteria, and data was not collected and/or analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'OG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'timeFrame': 'Baseline and Week 4', 'description': 'ESR (measured in mm/h), is a pro-inflammatory marker. Higher ESR levels are correlated with greater hidradenitis suppurativa disease activity and worse clinical outcome.', 'reportingStatus': 'POSTED', 'populationDescription': 'ESR data was not collected/aggregated and therefore not analyzed at any of the identified timepoints. Laboratory analyses were not conducted.'}, {'type': 'SECONDARY', 'title': 'Baseline Patient Satisfaction Likert Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'OG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'timeFrame': 'Baseline', 'description': 'Likert scale is a rating system that is designed to measure participant\'s overall attitude and perception regarding one\'s health and hidradenitis suppurativa. The scores range from 1 to 5 with "1" being "very unsatisfied" to "5" being "very satisfied". Higher scores indicate higher satisfaction.', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient satisfaction data was not collected/aggregated and therefore not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Satisfaction Likert Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'OG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'timeFrame': 'Days 2, 6, 14, and 28', 'description': 'Likert scale is a rating system that is designed to measure participant\'s overall attitude and perception regarding one\'s health and hidradenitis suppurativa. The scores range from 1 to 5 with "1" being "very unsatisfied" to "5" being "very satisfied". Higher scores indicate higher satisfaction.', 'reportingStatus': 'POSTED', 'populationDescription': 'Change from baseline data for patient satisfaction was not collected/aggregated and therefore not analyzed at any of the identified timepoints.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Interleukin-6 (IL-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'OG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'OG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'timeFrame': 'Baseline and Week 4', 'description': 'IL-6 (measured in pg/mL), is a pro-inflammatory cytokine. Higher IL-6 levels are correlated with greater hidradenitis suppurativa disease activity and worse clinical outcome.', 'reportingStatus': 'POSTED', 'populationDescription': 'IL-6 data was not collected/aggregated and therefore not analyzed at any of the identified timepoints. Laboratory analyses were not conducted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'FG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'FG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'FG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Subject missed appointment(s).', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nPlacebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.'}, {'id': 'BG001', 'title': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.'}, {'id': 'BG002', 'title': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.'}, {'id': 'BG003', 'title': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.\n\nIntralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': 'Age 20-29 years old', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Age 30-39 years old', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Age 40-49 years old', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Age 50-59 years old', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Age 60-69 years old', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'American Indian/Alaskan Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-12', 'size': 1863564, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-29T14:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'This study was administratively closed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2020-09-29', 'resultsFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2020-10-05', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-16', 'studyFirstPostDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Numeric Rating Scale (NRS)', 'timeFrame': 'Baseline, Days 2, 6, 14, and 28', 'description': 'Numeric Rating Scale is a pain scale scored with whole integers from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable". Higher score indicates worse pain.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HS-PGA) Score', 'timeFrame': 'Baseline and Week 4', 'description': 'HS-PGA is a six-staged physician global assessment tool (score ranges from 0 to 5) based on number of HS lesions including inflammatory and/or non-inflammatory nodules, abscesses, and draining fistulas. Higher HS-PGA score indicates more severe HS disease.'}, {'measure': 'Change From Baseline in C-reactive Protein (CRP)', 'timeFrame': 'Baseline and Week 4', 'description': 'CRP (measured in mg/dL) is an inflammatory marker. A higher value is correlated with more severe disease.'}, {'measure': 'Change From Baseline in Hidradenitis Suppurativa (HS) Lesion Size', 'timeFrame': 'Baseline and Week 4', 'description': 'HS lesion size will be measured using a metric ruler in centimeters. Measurement will be standardized according to greatest diameter as lesions will be measured from edge of one border to the edge of the opposite border.'}, {'measure': 'Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)', 'timeFrame': 'Baseline, Days 2, 6, 14, and 28', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered outcome measures that assesses physical, mental, and psychosocial health in adults and children. Clinical measures of health outcome includes physical function, mobility, pain, fatigue, emotional stress, ability to participate in social roles, sleep-related impairment, depressive symptoms/sadness, anxiety/fear, and anger. The scores are rated on a scale from 0 to 100 with "0" being "best functioning" and "100" being "worst functioning".'}, {'measure': 'Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.', 'timeFrame': 'Baseline', 'description': "Evaluate the morphologic changes in participant's skin from baseline, specifically assessing\n\n1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris\n2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.\n3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules."}, {'measure': 'Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.', 'timeFrame': 'Day 2', 'description': "Evaluate the morphologic changes in participant's skin from baseline, specifically assessing\n\n1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris\n2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.\n3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules."}, {'measure': 'Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.', 'timeFrame': 'Day 6', 'description': "Evaluate the morphologic changes in participant's skin from baseline, specifically assessing\n\n1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris\n2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.\n3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules."}, {'measure': 'Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.', 'timeFrame': 'Day 14', 'description': "Evaluate the morphologic changes in participant's skin from baseline, specifically assessing\n\n1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris\n2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.\n3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules."}, {'measure': 'Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.', 'timeFrame': 'Day 28', 'description': "Evaluate the morphologic changes in participant's skin from baseline, specifically assessing\n\n1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris\n2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.\n3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules."}, {'measure': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'Baseline and Week 4', 'description': 'ESR (measured in mm/h), is a pro-inflammatory marker. Higher ESR levels are correlated with greater hidradenitis suppurativa disease activity and worse clinical outcome.'}, {'measure': 'Baseline Patient Satisfaction Likert Scale', 'timeFrame': 'Baseline', 'description': 'Likert scale is a rating system that is designed to measure participant\'s overall attitude and perception regarding one\'s health and hidradenitis suppurativa. The scores range from 1 to 5 with "1" being "very unsatisfied" to "5" being "very satisfied". Higher scores indicate higher satisfaction.'}, {'measure': 'Change From Baseline in Patient Satisfaction Likert Scale', 'timeFrame': 'Days 2, 6, 14, and 28', 'description': 'Likert scale is a rating system that is designed to measure participant\'s overall attitude and perception regarding one\'s health and hidradenitis suppurativa. The scores range from 1 to 5 with "1" being "very unsatisfied" to "5" being "very satisfied". Higher scores indicate higher satisfaction.'}, {'measure': 'Change From Baseline in Interleukin-6 (IL-6)', 'timeFrame': 'Baseline and Week 4', 'description': 'IL-6 (measured in pg/mL), is a pro-inflammatory cytokine. Higher IL-6 levels are correlated with greater hidradenitis suppurativa disease activity and worse clinical outcome.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hidradenitis Suppurativa']}, 'descriptionModule': {'briefSummary': 'Currently, there is limited evidence showing increased resolution of HS flares with higher doses of intralesional triamcinolone (ILTAC) as well as a difference in side effect profile between the doses. The goal of this study is to determine the efficacy of treating HS flares with ILTAC-10, ILTAC-20 and ILTAC-40 and to investigate the side effect profile for each dose.', 'detailedDescription': "A double-blinded, randomized, placebo-controlled study examining the relative efficacy of ILTAC-10, ILTAC-20, and ILTAC-40 versus placebo for acute flares of HS in subjects with moderate to severe HS. The duration of the study will be approximately 4 weeks for each enrolled patient and will include an initial screening/randomization/treatment visit and a 4-week follow-up period. During the initial visit, subjects who meet the study's eligibility criteria will be randomized to receive either ILTAC-10, ILTAC-20, ILTAC-40, or placebo in a 1:1:1:1 ratio. Study subjects will then receive treatment or placebo. The follow-up period will be of 4 weeks and will consist of 3 phone calls and 1 live visit, including an end of study visit on week 4 after randomization."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 13 years old.\n* Subject must voluntarily sign and date an informed consent, approved by an independent ethics committee / institutional review board.\n* Subject is willing to comply with the procedures in this protocol.\n* The subject must be diagnosed with HS and receiving care at HSC\n* Subjects with Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score between 2 and 5\n* The subject must have an inflamed nodule or abscess at the time of enrollment.\n\nExclusion Criteria:\n\n* The subject has an HS-PGA score of 0 or 1\n* The subject has received ILTAC less than 8 days prior to the initial visit.\n* The subject does not have capacity to consent to the study.\n* The subject is has taken systemic steroids at least 4 weeks prior to the time of enrollment.\n* The subject has a known allergy or history of adverse reaction to steroids.\n* The subject is pregnant.\n* Subjects who have received a biologic therapy two weeks before and during the study period.'}, 'identificationModule': {'nctId': 'NCT04582669', 'briefTitle': 'Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa', 'orgStudyIdInfo': {'id': '2020-12227'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sodium Chloride 0.9%', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intralesional Triamcinolone 10 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.', 'interventionNames': ['Drug: Intralesional Triamcinolone 10 mg/mL']}, {'type': 'EXPERIMENTAL', 'label': 'Intralesional Triamcinolone 20 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.', 'interventionNames': ['Drug: Intralesional Triamcinolone 20 mg/mL']}, {'type': 'EXPERIMENTAL', 'label': 'Intralesional Triamcinolone 40 mg/mL', 'description': 'Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.', 'interventionNames': ['Drug: Intralesional Triamcinolone 40 mg/mL']}], 'interventions': [{'name': 'Intralesional Triamcinolone 10 mg/mL', 'type': 'DRUG', 'description': 'Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.', 'armGroupLabels': ['Intralesional Triamcinolone 10 mg/mL']}, {'name': 'Intralesional Triamcinolone 20 mg/mL', 'type': 'DRUG', 'description': 'Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.', 'armGroupLabels': ['Intralesional Triamcinolone 20 mg/mL']}, {'name': 'Intralesional Triamcinolone 40 mg/mL', 'type': 'DRUG', 'description': 'Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.', 'armGroupLabels': ['Intralesional Triamcinolone 40 mg/mL']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.', 'armGroupLabels': ['Sodium Chloride 0.9%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Steven Cohen', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Steven R Cohen, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine Montefiore Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}