Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-01-06 @ 7:13 PM
Study NCT ID:
NCT02805595
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2016-06-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mporter3@bidmc.harvard.edu', 'phone': '6176675834', 'title': 'Martina Porter - Associate Directory of Dermatology Research', 'organization': 'Beth Israel Deaconess Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study limitations include 1) small sample size and lack of a control group. 2) the lack of an established scoring system for assessing improvement in individual fistulas. 3) We were unable to determine full fistula dimensions over time with ultrasound. 4) This was a single team of clinical investigators; therefore, treatment efficacy cannot be assessed between study investigators who were not trained by the original investigators.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for 8 weeks for each subject.', 'description': 'Definition doe snot differ, expected adverse events listed in the ICF were not collected or reported as per institution IRB guidelines', 'eventGroups': [{'id': 'EG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'HS Physician Local Improvement Assessment - PAIN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'No Change', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Worsened', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '16 subjects completed the study and had percent score data for Baseline and Visit 4 comparison'}, {'type': 'PRIMARY', 'title': 'HS Physician Local Improvement Assessment - Fluid Leakage From Fistula', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '15subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}, {'type': 'PRIMARY', 'title': 'HS Physician Local Improvement Assessment - Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}, {'type': 'PRIMARY', 'title': 'HS Physician Local Improvement Assessment - Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}, {'type': 'PRIMARY', 'title': 'HS Physician Local Improvement Assessment - Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}, {'type': 'PRIMARY', 'title': 'HS Physician Local Improvement Assessment - Hardness of Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}, {'type': 'PRIMARY', 'title': 'HS Physician Local Improvement Assessment - Hotness of Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}, {'type': 'PRIMARY', 'title': 'HS Physician Local Improvement Assessment - Odor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}, {'type': 'SECONDARY', 'title': 'Numeric Rating Scale for Stinging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'visit 4', 'categories': [{'measurements': [{'value': '5', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and visit 4 (week 8)', 'description': 'Self-reported median stinging intensity during and directly after treatment with Hypertonic saline injections.\n\nPain with a score of 1 (no stinging at all) to 10 (worst possible stinging).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Median score for Baseline and Visit 4 visits for 15 subjects who completed both visits.'}, {'type': 'SECONDARY', 'title': 'Numeric Rating Scale for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3', 'spread': '2.14', 'groupId': 'OG000'}]}]}, {'title': 'Visit 4', 'categories': [{'measurements': [{'value': '6', 'spread': '2.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and visit 4 (week 8)', 'description': 'Self-reported median pain intensity during and directly after treatment with Hypertonic saline injections.\n\nPain with a score of 1 (no pain at all) to 10 (worst possible pain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline and Visit 4 pain scores were analyzed for 15 subjects who reported data for both visits.'}, {'type': 'SECONDARY', 'title': 'Length of Fistula', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.\n\n23.4% Hypertonic saline: Saline Injections'}], 'timeFrame': 'Baseline and visit 4 (week 8)', 'description': 'Measuring the length and the lumen of the fistulas using ultrasound if possible.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed or collected since measuring length of fistulas through ultrasound seemed not feasible. Measurement had to be taken from precise location at each visit for it to be accurate, but the fistula changed shape between visits which made is impossible to use these measures as an evaluation.'}, {'type': 'SECONDARY', 'title': 'Dermatology Life Quality Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.14', 'spread': '5.83', 'groupId': 'OG000'}]}]}, {'title': 'Visit 4', 'categories': [{'measurements': [{'value': '6.0', 'spread': '5.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and visit 4 (week 8)', 'description': "Number of subjects improving based upon patient-reported outcomes The Dermatology Life Quality Index (DLQI) is a validated general dermatology questionnaire that consists of 10 items that assess subject health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment)\n\nThe scoring of each question is as follows:\n\nVery much scored = 3 points, A lot scored = 2 points, A little scored = 1, Not at all scored = 0 points, Not relevant scored = 0 points, Question 7, 'prevented work or studying' scored = 3 points. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 (meaning maximum impact on quality of life) and a minimum of 0 (meaning no impact of skin disease on quality of life). The higher the score, the more quality of life is impaired.\n\n0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'DLQI score for subjects who had data for baseline and visit 4 (final visit)'}, {'type': 'SECONDARY', 'title': 'HS Patient Local Improvement Assessment - Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.\n\n23.4% Hypertonic saline: Saline Injections'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'no change', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'worsened', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}, {'type': 'SECONDARY', 'title': 'HS Patient Local Improvement Assessment - Fluid From Fistula', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}, {'type': 'SECONDARY', 'title': 'HS Patient Local Improvement Assessment - Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}, {'type': 'SECONDARY', 'title': 'HS Patient Local Improvement Assessment - Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}, {'type': 'SECONDARY', 'title': 'HS Patient Local Improvement Assessment - Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}, {'type': 'SECONDARY', 'title': 'HS Patient Local Improvement Assessment - Hardness of Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '17subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}, {'type': 'SECONDARY', 'title': 'HS Patient Local Improvement Assessment - Hotness of Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}, {'type': 'SECONDARY', 'title': 'HS Patient Local Improvement Assessment - Odor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '16subjects completed the study and had percent score data for Baseline and Visit 4 comparison. Not every subject had all fistula characteristic which is why total value is different for each separate characteristic.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.\n\n23.4% Hypertonic saline: Saline Injections'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.85', 'spread': '13.41', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Demographic data was measured for all pariticipants, outcome measures were measured for only 17 completed subjects who had data for all visits. Physician assessment were only reported for 16sujbects'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-22', 'size': 440741, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-15T11:31', 'hasProtocol': True}, {'date': '2018-10-23', 'size': 687985, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-15T11:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2016-06-10', 'resultsFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-11', 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HS Physician Local Improvement Assessment - PAIN', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}, {'measure': 'HS Physician Local Improvement Assessment - Fluid Leakage From Fistula', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}, {'measure': 'HS Physician Local Improvement Assessment - Erythema', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}, {'measure': 'HS Physician Local Improvement Assessment - Tenderness', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}, {'measure': 'HS Physician Local Improvement Assessment - Swelling', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}, {'measure': 'HS Physician Local Improvement Assessment - Hardness of Skin', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}, {'measure': 'HS Physician Local Improvement Assessment - Hotness of Skin', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}, {'measure': 'HS Physician Local Improvement Assessment - Odor', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in clinical efficacy will be measured by Physician Assessments: HS Physician Local Improvement Assessment. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPhysicians rated characteristics associated with fistula severity as "improved", "no change", "worsened": overall clinical state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}], 'secondaryOutcomes': [{'measure': 'Numeric Rating Scale for Stinging', 'timeFrame': 'Baseline and visit 4 (week 8)', 'description': 'Self-reported median stinging intensity during and directly after treatment with Hypertonic saline injections.\n\nPain with a score of 1 (no stinging at all) to 10 (worst possible stinging).'}, {'measure': 'Numeric Rating Scale for Pain', 'timeFrame': 'Baseline and visit 4 (week 8)', 'description': 'Self-reported median pain intensity during and directly after treatment with Hypertonic saline injections.\n\nPain with a score of 1 (no pain at all) to 10 (worst possible pain).'}, {'measure': 'Length of Fistula', 'timeFrame': 'Baseline and visit 4 (week 8)', 'description': 'Measuring the length and the lumen of the fistulas using ultrasound if possible.'}, {'measure': 'Dermatology Life Quality Index', 'timeFrame': 'Baseline and visit 4 (week 8)', 'description': "Number of subjects improving based upon patient-reported outcomes The Dermatology Life Quality Index (DLQI) is a validated general dermatology questionnaire that consists of 10 items that assess subject health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment)\n\nThe scoring of each question is as follows:\n\nVery much scored = 3 points, A lot scored = 2 points, A little scored = 1, Not at all scored = 0 points, Not relevant scored = 0 points, Question 7, 'prevented work or studying' scored = 3 points. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 (meaning maximum impact on quality of life) and a minimum of 0 (meaning no impact of skin disease on quality of life). The higher the score, the more quality of life is impaired.\n\n0-1 = No effect on patient's life, 2-5 = Small effect, 6-10 = Moderate effect, 11-20 = Very large effect, 21-30 = Extremely large effect."}, {'measure': 'HS Patient Local Improvement Assessment - Pain', 'timeFrame': 'Baseline to Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}, {'measure': 'HS Patient Local Improvement Assessment - Fluid From Fistula', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}, {'measure': 'HS Patient Local Improvement Assessment - Erythema', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}, {'measure': 'HS Patient Local Improvement Assessment - Tenderness', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}, {'measure': 'HS Patient Local Improvement Assessment - Swelling', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}, {'measure': 'HS Patient Local Improvement Assessment - Hardness of Skin', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}, {'measure': 'HS Patient Local Improvement Assessment - Hotness of Skin', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}, {'measure': 'HS Patient Local Improvement Assessment - Odor', 'timeFrame': 'Baseline and Visit 4 (week 8)', 'description': 'Percent change in Patient improvement assessment about state of the disease from baseline to visit 4. Scale allows physician to score multiple HS symptoms on a scale from \'extremely worse\' to \'very much improved\'.\n\nPatients rated characteristics associated with fistula severity as "improved", "no change", "worsened": Overall disease state of HS in treated area, pain, fluid leakage from fistula, erythema, tenderness on palpation, swelling, hardness of skin, hotness of skin, and odor.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hidradenitis Suppurativa']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.', 'detailedDescription': 'The clinical effect of the hypertonic saline treatment will be evaluated with Physician Assessments at week 2 (t=2), week four (t=4) and week 8 (t=8) and compared with the first visit (baseline) (t=0). If necessary, subjects will be eligible to receive another hypertonic saline injected in week 2 and/or week 4, with a maximum of three injections. Simultaneously improvement will be assessed by ultrasound if possible, using the Philips Lumify Ultrasound Device, and by patients using HS Improvement Assessments. Pain and stinging during treatment sessions will be monitored using numeric rating scales (NRS). For monitoring quality of life the DLQI will be used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects are at least 18 years of age or older\n* A confirmed diagnosis of HS disease\n* Presence of inflammatory HS lesion(s) and one or more fistula(s) or sinus tracts\n\nExclusion Criteria:\n\n* Receiving any other kind of treatment for fistulas including introduction of anti-inflammatory systemic therapy such as prednisone or adalimumab within the prior month.\n* Are participating in another study using an investigational agent or procedure during participation in this study.\n* Are currently pregnant or planning to get pregnant during the study.\n* Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.'}, 'identificationModule': {'nctId': 'NCT02805595', 'briefTitle': 'Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'A Single Center Clinical Trial to Evaluate the Effect of Sclerotherapy on Fistulas and Sinus Tracts in Adult Patients With Hidradenitis Suppurativa', 'orgStudyIdInfo': {'id': '2016P001274'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypertonic Saline', 'description': '23.4% Hypertonic Saline injection(s) with a maximum of 0.4cc per treatment. If necessary every two weeks, with a maximum of three treatments.', 'interventionNames': ['Drug: 23.4% Hypertonic saline']}], 'interventions': [{'name': '23.4% Hypertonic saline', 'type': 'DRUG', 'otherNames': ['23.4% sodium chloride'], 'description': 'Saline Injections', 'armGroupLabels': ['Hypertonic Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Martina Porter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor in Dermatology', 'investigatorFullName': 'Martina Porter', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}