Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 4:52 PM
Study NCT ID:
NCT03472534
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2018-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C025292', 'term': 'diacerein'}, {'id': 'D009824', 'term': 'Ointments'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mspellman@castlecreekpharma.com', 'phone': '862-286-0400', 'title': 'Dr. Mary Spellman/Chief Medical Officer', 'organization': 'Castle Creek Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There were no limitations or caveats on this study.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event collection occurred from timing of first dose until completion of last study visit, i.e., 21 days.', 'description': 'Adverse events were not assessed at a patch site-specific level.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Cohort (Healthy Volunteers)', 'description': "Diacerein 1% ointment, vehicle ointment, 0.2% sodium lauryl sulfate (SLS; positive control), and 0.9% saline (negative control) were applied at 4 randomly assigned, adjacent skin sites on the infrascapular area of each subject's back once daily for 21 consecutive days.", 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Skin Irritation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}, {'units': 'Patch sites', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Cohort (Healthy Volunteers)', 'description': "Diacerein 1% ointment, vehicle ointment, 0.2% sodium lauryl sulfate (SLS; positive control), and 0.9% saline (negative control) were applied at 4 randomly assigned, adjacent skin sites on the infrascapular area of each subject's back once daily for 21 consecutive days."}], 'classes': [{'title': 'Diacerein 1% ointment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}, {'units': 'Patch sites', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Vehicle 1% ointment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}, {'units': 'Patch sites', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '0.2% sodium lauryl sulfate (SLS) (positive control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}, {'units': 'Patch sites', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000'}]}]}, {'title': '0.9% saline (negative control)" Arms/Groups)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}, {'units': 'Patch sites', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The p-value for the overall F-test was used to determine if the mean irritation scores were equal for all four products.'}], 'paramType': 'NUMBER', 'timeFrame': 'Daily for 21 days', 'description': "Evaluation of the sum of all subjects' cumulative irritation scores for 21 days at each patch site.\n\nCumulative Irritation Score is a visual score rating the degree of erythema, edema, and other signs of cutaneous irritation: Minimum = 0; Maximum = 6; higher score is worse outcome.", 'unitOfMeasure': 'Normalized cumulative irritation score', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Patch sites', 'denomUnitsSelected': 'Patch sites', 'populationDescription': 'Per Protocol Population includes all subjects who completed the study with 21 evaluations of irritancy or who discontinued patch sites due to limiting irritation, and was used for analysis of cumulative irritation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Cohort (Healthy Volunteers)', 'description': "Diacerein 1% ointment, vehicle ointment, 0.2% sodium lauryl sulfate (SLS; positive control), and 0.9% saline (negative control) were applied at 4 randomly assigned, adjacent skin sites on the infrascapular area of each subject's back once daily for 21 consecutive days."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Each participant receives all 4 unit interventions.', 'groupId': 'FG000', 'numUnits': '184', 'numSubjects': '46'}]}, {'type': 'Diacerein 1% Ointment', 'achievements': [{'groupId': 'FG000', 'numUnits': '46', 'numSubjects': '46'}]}, {'type': 'Vehicle Ointment', 'achievements': [{'groupId': 'FG000', 'numUnits': '46', 'numSubjects': '46'}]}, {'type': '0.2% Sodium Lauryl Sulfate (SLS)', 'achievements': [{'groupId': 'FG000', 'numUnits': '46', 'numSubjects': '46'}]}, {'type': '0.9% Saline', 'achievements': [{'groupId': 'FG000', 'numUnits': '46', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '140', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '44', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'typeUnitsAnalyzed': 'skin patch test sites', 'preAssignmentDetails': 'This does not apply'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Cohort (Healthy Volunteers)', 'description': "Diacerein 1% ointment, vehicle ointment, 0.2% sodium lauryl sulfate (SLS; positive control), and 0.9% saline (negative control) were applied at 4 randomly assigned, adjacent skin sites on the infrascapular area of each subject's back once daily for 21 consecutive days."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Count of Participants', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', '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': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-23', 'size': 595621, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-16T14:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Cumulative irritancy patch test (CIPT) procedure. All subjects received once daily applications of 0.2mL of diacerein 1% ointment under occlusive patch for 21 days.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2018-01-30', 'resultsFirstSubmitDate': '2019-08-05', 'studyFirstSubmitQcDate': '2018-03-14', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-27', 'studyFirstPostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Irritation Score', 'timeFrame': 'Daily for 21 days', 'description': "Evaluation of the sum of all subjects' cumulative irritation scores for 21 days at each patch site.\n\nCumulative Irritation Score is a visual score rating the degree of erythema, edema, and other signs of cutaneous irritation: Minimum = 0; Maximum = 6; higher score is worse outcome."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate the irritation potential of diacerein1% ointment on normal skin of healthy volunteers, using a cumulative irritancy patch test (CIPT) procedure.', 'detailedDescription': 'This study was designed to assess the cumulative irritation potential of diacerein 1% ointment in comparison with vehicle ointment, 0.2% sodium lauryl sulfate (SLS) (positive control), and 0.9% saline (negative control) on normal skin of healthy volunteers using a cumulative irritancy patch test (CIPT) procedure applied once daily for 21 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Is a healthy male or female (to be confirmed by medical history);\n* Is 18 years of age or older;\n* In the case of a female of childbearing potential, is using two acceptable forms of birth control;\n* In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS);\n* Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs;\n* Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema\n\nKey Exclusion Criteria:\n\n* Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;\n* Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;\n* Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin, (occasional use of acetaminophen will be permitted);\n* Is using medication which, in the opinion of the Investigator, will interfere with the study results;\n* Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;\n* Has psoriasis and/or active atopic dermatitis/eczema;\n* Has a known sensitivity or allergy to constituents of the materials being evaluated including diacerein, mineral oil, petrolatum, cetyl alcohol, D\\&C Yellow #10 and/or ethyl paraben;\n* Has damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;\n* Has received treatment for any type of internal cancer within 5 years prior to study entry;\n* Has any known sensitivity to adhesives; and/or\n* Has received any investigational drug(s) within 4 weeks prior to study entry'}, 'identificationModule': {'nctId': 'NCT03472534', 'briefTitle': 'A 21 Day Irritation Study in Healthy Volunteers With Diacerein 1% Ointment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Castle Creek Pharmaceuticals, LLC'}, 'officialTitle': 'A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of CCP-020 (Diacerein 1%) Topical Ointment in Healthy Subjects Using a Cumulative Irritant Patch Test Design', 'orgStudyIdInfo': {'id': 'CCP-020-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'study in healthy volunteers', 'description': 'diacerein 1% ointment', 'interventionNames': ['Drug: diacerein 1% ointment']}], 'interventions': [{'name': 'diacerein 1% ointment', 'type': 'DRUG', 'otherNames': ['CCP-020'], 'description': 'diacerein 1% ointment applied to the skin of the infrascapular area of the back under occlusive patch for 21 days.', 'armGroupLabels': ['study in healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07410', 'city': 'Fair Lawn', 'state': 'New Jersey', 'country': 'United States', 'facility': 'TKL Research', 'geoPoint': {'lat': 40.94038, 'lon': -74.13181}}], 'overallOfficials': [{'name': 'Mary Spellman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Castle Creek Pharmaceuticals, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Castle Creek Pharmaceuticals, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'TKL Research, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}