Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-01 @ 3:01 PM
Study NCT ID:
NCT02457520
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2015-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ABSORICA in Patients With Severe Recalcitrant Nodular Acne
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015474', 'term': 'Isotretinoin'}], 'ancestors': [{'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@sparcmail.com', 'phone': '912266455645', 'title': 'Clinical Trials', 'organization': 'SPIL'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Active Treatment Period- 20 weeks Post-treatment Period- 124 weeks', 'description': 'All safety analyses were carried out using the safety population, which was defined as all subjects who received at least 1 dose of study treatment. Thus, overall results are depicted for all the subjects', 'eventGroups': [{'id': 'EG000', 'title': 'Single Treatment Arm', 'description': 'Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks.\n\nStudy ABS1517LT was a Phase 4, open-label, single-arm study in subjects with severe recalcitrant nodular acne, consisting of 2 phases: a 20-week (5-month) Active Treatment Phase and a 104-week (2-year) Post Treatment Period.', 'otherNumAtRisk': 201, 'deathsNumAtRisk': 201, 'otherNumAffected': 54, 'seriousNumAtRisk': 201, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Active Treatment Period: Total Acne-Specific Quality of Life Score at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '100.7', 'spread': '18.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 20', 'description': 'There are 4 domains: self-perception (22 questions), role-social (50 questions), role-emotional (33 questions), and acne symptoms (85 questions) in the acne-QOL questionnaires.\n\nCalculation of the domain scores was accomplished by summing all item responses within each domain.\n\nSelf-perception: The range of possible scores is 0 to 30 points. Role-social: The range of possible scores is 0 to 24 points. Role emotional: The domain scores range from 0 to 30 points. Acne symptoms: The domain scores range from 0 to 30 points.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint was analyzed in the per-protocol population and the number of participants analyzed in the per-protocol population set was 166.'}, {'type': 'PRIMARY', 'title': 'Primary Efficacy Endpoint, Post-treatment Period: Subjects Requiring Retreatment During the Post-treatment Period and Time to Retreatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '20 weeks', 'description': 'subjects who were at least 75% compliant with their assigned treatment, had no major protocol violations, had a Week 20 count of total nodular lesions, and did not use any disallowed medications during the 20 weeks of treatment. (Retreated with Oral Isotretinoin Per Protocol Population).', 'unitOfMeasure': 'number of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'SECONDARY', 'title': 'Active Treatment Period- Change From Baseline in Lesion Counts at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-89.14', 'spread': '16.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at week 20', 'description': 'Change from baseline in the lesion count (nodules and inflammatory lesions) at the end of the ATP. (Per Protocol Population)', 'unitOfMeasure': 'percentage change in lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Active Treatment Period-Change From Baseline in Acne-Specific Quality of Life Total Score at Weeks 4, 8, 12, and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}, {'value': '149', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm-Week 16', 'description': 'Visit 7/Week 16\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG001', 'title': 'Single Treatment Arm-Week 12', 'description': 'Visit 6/Week 12\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG002', 'title': 'Single Treatment Arm-Week 8', 'description': 'Visit 5/Week 8\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG003', 'title': 'Single Treatment Arm-Week 4', 'description': 'Visit 4/Week 4\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'spread': '28.1', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '24.6', 'groupId': 'OG001'}, {'value': '17.8', 'spread': '22.4', 'groupId': 'OG002'}, {'value': '14.5', 'spread': '19.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, at week 4, week 8, week 12, and week16', 'description': 'There are 4 domains: self-perception (22 questions), role-social (50 questions), role-emotional (33 questions), and acne symptoms (85 questions) in the acne-QOL questionnaires.\n\nCalculation of the domain scores was accomplished by summing all item responses within each domain.\n\nSelf-perception: The range of possible scores is 0 to 30 points. Role-social: The range of possible scores is 0 to 24 points. Role emotional: The domain scores range from 0 to 30 points. Acne symptoms: The domain scores range from 0 to 30 points.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population'}, {'type': 'SECONDARY', 'title': "Active Treatment Period- Investigator's Global Assessment at Week 20", 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 20', 'description': "Investigator's Global Assessment score:\n\n0 = Clear\n\n1. = Almost Clear\n2. = Mild\n3. = Moderate\n4. = Severe\n5. = Very Severe", 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Active Treatment Period- Change From Baseline in Acne-Specific Quality of Life Domain Scores by Domain at Weeks 4, 8, 12, and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '166', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm-Self Perception', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG001', 'title': 'Single Treatment Arm-Role-Emotional', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG002', 'title': 'Single Treatment Arm-Role-Social', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG003', 'title': 'Single Treatment Arm-Acne Symptoms', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'title': 'Visit 8/Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '166', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.6', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '7.1', 'groupId': 'OG002'}, {'value': '11.6', 'spread': '6.1', 'groupId': 'OG003'}]}]}, {'title': 'Visit 7/Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}, {'value': '159', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '7.1', 'groupId': 'OG002'}, {'value': '9.7', 'spread': '6.2', 'groupId': 'OG003'}]}]}, {'title': 'Visit 6/Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}, {'value': '163', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '6.0', 'groupId': 'OG002'}, {'value': '8.2', 'spread': '5.9', 'groupId': 'OG003'}]}]}, {'title': 'Visit 5/Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}, {'value': '162', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '7.1', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '5.3', 'groupId': 'OG002'}, {'value': '6.1', 'spread': '5.6', 'groupId': 'OG003'}]}]}, {'title': 'Visit 4/Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '149', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '6.5', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '5.2', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '5.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 weeks', 'description': 'Acne-Specific Quality of Life, by domain:\n\nSelf Perception: response on 0- to 6-point scale; the range of possible scores is 0 to 30 points.\n\nRole-social: response on 0- to 6-point scale; the range of possible scores is 0 to 24 points.\n\nRole-emotional: response on 0- to 6-point scale, exactly the same as those used for the Self Perception and Role-social domains.\n\nAcne Symptoms:response on 0- to 6-point scale, domain scores range from 0 to 30 points', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol population'}, {'type': 'SECONDARY', 'title': 'Active Treatment Period- Change From Baseline in Nodule Count at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-96.18', 'spread': '11.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and at week20', 'unitOfMeasure': 'percentage change in nodule count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post-treatment Period- Proportion of Subjects Requiring Treatment With Anti-Acne Medication and Time to Retreatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm-Retreat With Prescription Anti-acne Medic', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG001', 'title': 'Single Treatment Arm - Retreat With Over-the-counter Anti-acne', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG002', 'title': 'Single Treatment Arm- Retreat With Prescription or Over-the-co', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '104 weeks', 'description': 'Retreated with Prescription Anti-Acne Medication, n/Na (%); Over-the-Counter Anti-Acne Medication and Prescription or Over-the-Counter Anti-Acne Medication- Per Protocol Population.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population'}, {'type': 'SECONDARY', 'title': 'Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm- Total', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG001', 'title': 'Single Treatment Arm -Non-inflammatory', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG002', 'title': 'Single Treatment Arm-Inflammatory', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.81', 'spread': '31.15', 'groupId': 'OG000'}, {'value': '-1.41', 'spread': '95.81', 'groupId': 'OG001'}, {'value': '-31.53', 'spread': '19.78', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '104 weeks', 'description': 'change from Baseline', 'unitOfMeasure': 'percentage change in lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'SECONDARY', 'title': "Post-treatment Period- Severity of Acne by Investigator's Global Assessment at Time of Retreatment With Oral Isotretinoin", 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '104 weeks', 'description': "Investigator's Global Assessment score:\n\n0 = Clear\n\n1. = Almost Clear\n2. = Mild\n3. = Moderate\n4. = Severe\n5. = Very Severe", 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'SECONDARY', 'title': 'Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm-Inflammatory', 'description': 'Change from baseline\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG001', 'title': 'Single Treatment Arm -Non-inflammatory', 'description': 'Change from baseline\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG002', 'title': 'Single Treatment Arm- Total', 'description': 'Change from baseline\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-66.16', 'spread': '25.93', 'groupId': 'OG000'}, {'value': '-72.90', 'spread': '30.52', 'groupId': 'OG001'}, {'value': '-69.83', 'spread': '22.48', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '104 weeks', 'description': 'Change from baseline', 'unitOfMeasure': 'percentage change in lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '(Per Protocol Population)'}, {'type': 'SECONDARY', 'title': "Post-treatment Period- Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Over-the-Counter Medication", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 weeks', 'description': "Investigator's Global Assessment score:\n\n0 = Clear\n\n1. = Almost Clear\n2. = Mild\n3. = Moderate\n4. = Severe\n5. = Very Severe", 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population'}, {'type': 'SECONDARY', 'title': 'Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm-Inflammatory', 'description': 'Change from Baseline\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG001', 'title': 'Single Treatment Arm -Non-inflammatory', 'description': 'Change from Baseline\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG002', 'title': 'Single Treatment Arm- Total', 'description': 'Change from Baseline\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-86.85', 'spread': '18.89', 'groupId': 'OG000'}, {'value': '-80.45', 'spread': '37.10', 'groupId': 'OG001'}, {'value': '-85.35', 'spread': '21.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 124', 'unitOfMeasure': 'percentage change in lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP Population'}, {'type': 'SECONDARY', 'title': 'Post Treatment Period- Severity of Acne by Nodule Count at Each Visit During the Post-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-99.03', 'spread': '5.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 124', 'description': 'Change from Baseline-Week 124', 'unitOfMeasure': 'percentage change in lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population'}, {'type': 'SECONDARY', 'title': "Severity of Acne by Investigator's Global Assessment Score at Each Visit During the Post-treatment Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 124', 'description': "Investigator's Global Assessment score:\n\n0 = Clear\n\n1. = Almost Clear\n2. = Mild\n3. = Moderate\n4. = Severe\n5. = Very Severe", 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol population'}, {'type': 'SECONDARY', 'title': 'Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm-Inflammatory', 'description': 'Change from Baseline\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG001', 'title': 'Single Treatment Arm -Non-inflammatory', 'description': 'Change from Baseline\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG002', 'title': 'Single Treatment Arm- Total', 'description': 'Change from Baseline\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-66.61', 'spread': '17.26', 'groupId': 'OG000'}, {'value': '-63.70', 'spread': '38.38', 'groupId': 'OG001'}, {'value': '-67.04', 'spread': '21.87', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 weeks', 'description': 'Change from Baseline', 'unitOfMeasure': 'percentage change in lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '(Per Protocol Population)'}, {'type': 'SECONDARY', 'title': "Post Treatment Period-Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Prescription Other Than Oral Isotretinoin", 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm', 'description': 'Change from Baseline\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 weeks', 'description': "Investigator's Global Assessment score:\n\n0 = Clear\n\n1. = Almost Clear\n2. = Mild\n3. = Moderate\n4. = Severe\n5. = Very Severe", 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '(Per Protocol Population)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Post Treatment Period- Acne-Specific Quality of Life by Total Scores at the End of the Post-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm- Visit 14/ Week 124', 'description': 'Change from Baseline\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'spread': '29.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 14/Week 124', 'description': 'There are 4 domains: self-perception (22 questions), role-social (50 questions), role-emotional (33 questions), and acne symptoms (85 questions) in the acne-QOL questionnaires.\n\nCalculation of the domain scores was accomplished by summing all item responses within each domain.\n\nSelf-perception: The range of possible scores is 0 to 30 points. Role-social: The range of possible scores is 0 to 24 points. Role emotional: The domain scores range from 0 to 30 points. Acne symptoms: The domain scores range from 0 to 30 points.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Post-treatment Period- Acne-Specific Quality of Life by Domain Scores at the End of the Post-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Treatment Arm-Self Perception', 'description': 'Change from Baseline\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG001', 'title': 'Single Treatment Arm-Role-Emotional', 'description': 'Change from Baseline\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG002', 'title': 'Single Treatment Arm-Role-Social', 'description': 'Change from Baseline\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.\n\nIsotretinoin: ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks'}, {'id': 'OG003', 'title': 'Single Treatment Arm-Acne Symptoms', 'description': 'Change from Baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '7.7', 'spread': '7.5', 'groupId': 'OG002'}, {'value': '11.5', 'spread': '6.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 14/Week 124', 'description': 'Acne-Specific Quality of Life, total and by domain:\n\nSelf Perception: response on 0- to 6-point scale; the range of possible scores is 0 to 30 points.\n\nRole-social: response on 0- to 6-point scale; the range of possible scores is 0 to 24 points.\n\nRole-emotional: response on 0- to 6-point scale, exactly the same as those used for the Self Perception and Role-social domains.\n\nAcne Symptoms:response on 0- to 6-point scale, domain scores range from 0 to 30 points', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Treatment Arm', 'description': 'Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks.'}], 'periods': [{'title': 'Active Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All subjects received treatment according to the same regimen.', 'groupId': 'FG000', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'comment': 'Subjects Completing Treatment Phase, n (%)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Non-compliance with Study Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}, {'title': 'Post-treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Other: Retreatment Required', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Treatment Arm', 'description': 'Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.7', 'spread': '6.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '125', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '170', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': 'NA', 'comment': 'Only Hispanic or Latino and Non-Hispanic or Latino were included in the study', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '167', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '201', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'safety population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-12-19', 'size': 3908194, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-10T00:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2015-05-16', 'resultsFirstSubmitDate': '2019-12-10', 'studyFirstSubmitQcDate': '2015-05-28', 'lastUpdatePostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-26', 'studyFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Post Treatment Period- Acne-Specific Quality of Life by Total Scores at the End of the Post-treatment Period', 'timeFrame': 'Visit 14/Week 124', 'description': 'There are 4 domains: self-perception (22 questions), role-social (50 questions), role-emotional (33 questions), and acne symptoms (85 questions) in the acne-QOL questionnaires.\n\nCalculation of the domain scores was accomplished by summing all item responses within each domain.\n\nSelf-perception: The range of possible scores is 0 to 30 points. Role-social: The range of possible scores is 0 to 24 points. Role emotional: The domain scores range from 0 to 30 points. Acne symptoms: The domain scores range from 0 to 30 points.'}, {'measure': 'Post-treatment Period- Acne-Specific Quality of Life by Domain Scores at the End of the Post-treatment Period', 'timeFrame': 'Visit 14/Week 124', 'description': 'Acne-Specific Quality of Life, total and by domain:\n\nSelf Perception: response on 0- to 6-point scale; the range of possible scores is 0 to 30 points.\n\nRole-social: response on 0- to 6-point scale; the range of possible scores is 0 to 24 points.\n\nRole-emotional: response on 0- to 6-point scale, exactly the same as those used for the Self Perception and Role-social domains.\n\nAcne Symptoms:response on 0- to 6-point scale, domain scores range from 0 to 30 points'}], 'primaryOutcomes': [{'measure': 'Active Treatment Period: Total Acne-Specific Quality of Life Score at Week 20', 'timeFrame': 'Week 20', 'description': 'There are 4 domains: self-perception (22 questions), role-social (50 questions), role-emotional (33 questions), and acne symptoms (85 questions) in the acne-QOL questionnaires.\n\nCalculation of the domain scores was accomplished by summing all item responses within each domain.\n\nSelf-perception: The range of possible scores is 0 to 30 points. Role-social: The range of possible scores is 0 to 24 points. Role emotional: The domain scores range from 0 to 30 points. Acne symptoms: The domain scores range from 0 to 30 points.'}, {'measure': 'Primary Efficacy Endpoint, Post-treatment Period: Subjects Requiring Retreatment During the Post-treatment Period and Time to Retreatment', 'timeFrame': '20 weeks', 'description': 'subjects who were at least 75% compliant with their assigned treatment, had no major protocol violations, had a Week 20 count of total nodular lesions, and did not use any disallowed medications during the 20 weeks of treatment. (Retreated with Oral Isotretinoin Per Protocol Population).'}], 'secondaryOutcomes': [{'measure': 'Active Treatment Period- Change From Baseline in Lesion Counts at Week 20', 'timeFrame': 'Baseline and at week 20', 'description': 'Change from baseline in the lesion count (nodules and inflammatory lesions) at the end of the ATP. (Per Protocol Population)'}, {'measure': 'Active Treatment Period-Change From Baseline in Acne-Specific Quality of Life Total Score at Weeks 4, 8, 12, and 16', 'timeFrame': 'Baseline, at week 4, week 8, week 12, and week16', 'description': 'There are 4 domains: self-perception (22 questions), role-social (50 questions), role-emotional (33 questions), and acne symptoms (85 questions) in the acne-QOL questionnaires.\n\nCalculation of the domain scores was accomplished by summing all item responses within each domain.\n\nSelf-perception: The range of possible scores is 0 to 30 points. Role-social: The range of possible scores is 0 to 24 points. Role emotional: The domain scores range from 0 to 30 points. Acne symptoms: The domain scores range from 0 to 30 points.'}, {'measure': "Active Treatment Period- Investigator's Global Assessment at Week 20", 'timeFrame': 'week 20', 'description': "Investigator's Global Assessment score:\n\n0 = Clear\n\n1. = Almost Clear\n2. = Mild\n3. = Moderate\n4. = Severe\n5. = Very Severe"}, {'measure': 'Active Treatment Period- Change From Baseline in Acne-Specific Quality of Life Domain Scores by Domain at Weeks 4, 8, 12, and 16', 'timeFrame': '20 weeks', 'description': 'Acne-Specific Quality of Life, by domain:\n\nSelf Perception: response on 0- to 6-point scale; the range of possible scores is 0 to 30 points.\n\nRole-social: response on 0- to 6-point scale; the range of possible scores is 0 to 24 points.\n\nRole-emotional: response on 0- to 6-point scale, exactly the same as those used for the Self Perception and Role-social domains.\n\nAcne Symptoms:response on 0- to 6-point scale, domain scores range from 0 to 30 points'}, {'measure': 'Active Treatment Period- Change From Baseline in Nodule Count at Week 20', 'timeFrame': 'Baseline, and at week20'}, {'measure': 'Post-treatment Period- Proportion of Subjects Requiring Treatment With Anti-Acne Medication and Time to Retreatment', 'timeFrame': '104 weeks', 'description': 'Retreated with Prescription Anti-Acne Medication, n/Na (%); Over-the-Counter Anti-Acne Medication and Prescription or Over-the-Counter Anti-Acne Medication- Per Protocol Population.'}, {'measure': 'Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Oral Isotretinoin', 'timeFrame': '104 weeks', 'description': 'change from Baseline'}, {'measure': "Post-treatment Period- Severity of Acne by Investigator's Global Assessment at Time of Retreatment With Oral Isotretinoin", 'timeFrame': '104 weeks', 'description': "Investigator's Global Assessment score:\n\n0 = Clear\n\n1. = Almost Clear\n2. = Mild\n3. = Moderate\n4. = Severe\n5. = Very Severe"}, {'measure': 'Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Prescription Other Than Oral Isotretinoin', 'timeFrame': '104 weeks', 'description': 'Change from baseline'}, {'measure': "Post-treatment Period- Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Over-the-Counter Medication", 'timeFrame': '20 weeks', 'description': "Investigator's Global Assessment score:\n\n0 = Clear\n\n1. = Almost Clear\n2. = Mild\n3. = Moderate\n4. = Severe\n5. = Very Severe"}, {'measure': 'Post-treatment Period-Severity of Acne by Lesion Count at Each Visit During the Post-treatment Period', 'timeFrame': 'week 124'}, {'measure': 'Post Treatment Period- Severity of Acne by Nodule Count at Each Visit During the Post-treatment Period', 'timeFrame': 'week 124', 'description': 'Change from Baseline-Week 124'}, {'measure': "Severity of Acne by Investigator's Global Assessment Score at Each Visit During the Post-treatment Period", 'timeFrame': 'week 124', 'description': "Investigator's Global Assessment score:\n\n0 = Clear\n\n1. = Almost Clear\n2. = Mild\n3. = Moderate\n4. = Severe\n5. = Very Severe"}, {'measure': 'Post-treatment Period- Severity of Acne by Lesion Count at Time of Retreatment With Over-the-Counter Medications', 'timeFrame': '20 weeks', 'description': 'Change from Baseline'}, {'measure': "Post Treatment Period-Severity of Acne by Investigator's Global Assessment Score at Time of Retreatment With Prescription Other Than Oral Isotretinoin", 'timeFrame': '20 weeks', 'description': "Investigator's Global Assessment score:\n\n0 = Clear\n\n1. = Almost Clear\n2. = Mild\n3. = Moderate\n4. = Severe\n5. = Very Severe"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne']}, 'referencesModule': {'references': [{'pmid': '32038751', 'type': 'DERIVED', 'citation': 'Del Rosso JQ, Stein Gold L, Segal J, Zaenglein AL. An Open-label, Phase IV Study Evaluating Lidose-isotretinoin Administered without Food in Patients with Severe Recalcitrant Nodular Acne: Low Relapse Rates Observed Over the 104-week Post-treatment Period. J Clin Aesthet Dermatol. 2019 Nov;12(11):13-18. Epub 2019 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.\n\nABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Female subjects consenting to use two forms of birth control or abstinence are included.', 'detailedDescription': 'This study is designed to collect efficacy, safety, and quality of life (QOL) data from subjects who receive Absorica® without food. The study will investigate the treatment efficacy, frequency of relapse once the treatment has been discontinued, quality of life during the active treatment and during a 2-year post treatment period and the overall safety of treatment with Absorica®.\n\nThis is a single-arm, open-label study consisting of 2 phases: a 20-week (5-month) open-label Active Treatment Period (ATP) and a 104-week (2-year) post treatment period (PTP). The total study duration is to be 124 weeks, excluding a screening period. During the ATP, after week 2 visit, visits will be scheduled at 4-week intervals for a total of 8 visits (1 screening visit, 1 baseline visit, and 6 on-study visits). During the PTP, the first visit will be 4 weeks after End of Treatment (EOT), the second visit will be 12 weeks after EOT, and subsequent visits will be scheduled at 26-week (± 2 weeks) intervals for a total of 6 visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "General Inclusion Criteria Subjects must meet the following mandatory inclusion criteria at the time of screening to be eligible to enter the study and must agree to conform to the requirements of the study and the iPLEDGE program.\n\n* Written informed consent, including mandatory photographic consent, on a gender-specific informed consent form (ICF) \\& Health Insurance Portability and Accountability Act (HIPAA) authorization prior to the performance of any study-related procedures.\n* Pregnant females and females who are not to become pregnant during the ATP phase of the trial and for 30 days after receiving their last dose of study drug.\n* Female subjects of childbearing potential ready to use 2 forms of effective contraception simultaneously for 1 month before starting Absorica® (isotretinoin), while taking Absorica® \\& for 1 month after Absorica® has been stopped.\n* Male and female subjects of non-childbearing potential\n\nSpecific Inclusion Criteria:\n\n* Severe recalcitrant nodular acne.\n* Five or more nodule lesions on the face.\n* Treatment-naïve subjects.\n* Age between 12 and 45 years.\n* Weight between 40 and 110 kg.\n* Female subjects of childbearing potential only: Negative results from serum pregnancy tests with a sensitivity of at least 25 milli-international unit/mL.\n* Good general health as determined by the investigator based on the subject's medical history, physical examination, vital signs measurements, and laboratory test results.\n* Subjects who present with stable \\& controlled diabetes mellitus (Types I and II).\n* Subjects with previously diagnosed polycystic ovarian syndrome (PCOS) can be included in the study if in the opinion of the investigator they do not have any other clinically significant abnormality (eg, metabolic syndrome or elevated lipids\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria\n\n* Presence of any clinically significant physical examination finding, vital signs measurement, or abnormal laboratory value;\n* Presence of a beard or other facial hair that could interfere with the study assessments;\n* Participated in another clinical trial or received an investigational product within 3 months prior to screening;\n* History of excessive or suspected abuse of alcohol (based on the clinical judgment of the investigator), recreational drugs, and/or drugs of abuse, e.g., club drugs, cocaine, ecstasy/ methylenedioxymethamphetamine, heroin, inhalants, marijuana, methamphetamine, phencyclidine, prescription medications, anabolic steroids, etc.\n* Use of prohibited or restricted prior or concomitant medications. Female Specific Exclusion Criteria\n* Are pregnant;\n* Are at a high risk for becoming pregnant or likely to become pregnant during treatment;\n* Are breast-feeding or considering breast-feeding during the course of the study;\n* Have a known history of PCOS with another clinically significant abnormality (eg, metabolic syndrome or elevated lipids);\n* Are unable or unwilling to maintain compliance with birth control measures"}, 'identificationModule': {'nctId': 'NCT02457520', 'briefTitle': 'ABSORICA in Patients With Severe Recalcitrant Nodular Acne', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries Limited'}, 'officialTitle': 'An Open-label Study Evaluating the Long-term Efficacy, Quality of Life, and Safety of ABSORICA® (Isotretinoin) Capsules Administered Without Food in Patients With Severe Recalcitrant Nodular Acne', 'orgStudyIdInfo': {'id': 'ABS157LT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single treatment arm', 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks.', 'interventionNames': ['Drug: Isotretinoin']}], 'interventions': [{'name': 'Isotretinoin', 'type': 'DRUG', 'otherNames': ['ABSORICA'], 'description': 'ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks', 'armGroupLabels': ['Single treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78218', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Dermatology and Laser Specialists', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Ashish Anvekar, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ranbaxy Laboratories Limited'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}