Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-02-27 @ 4:33 PM
Study NCT ID:
NCT02850003
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2016-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-20', 'studyFirstSubmitDate': '2016-07-06', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluators Global Severity Score At Day 15', 'timeFrame': '15 Days', 'description': 'Acne severity will be determined by the investigator/evaluator based on the global assessment of the inflammatory and non-inflammatory lesions of facial acne. Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne']}, 'descriptionModule': {'briefSummary': 'Study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.', 'detailedDescription': 'An Open-label study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Male or female between the ages of 9 and \\<17 (16 years 11 months)\n* Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or legal guardian must sign the informed consent.\n* Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment.\n* Subject with facial acne inflammatory lesion count no less than 20 but no more than 40.\n* Subject with facial acne non-inflammatory lesion count no less than 20 but no more than 100.\n\nKey Exclusion Criteria:\n\n* Use of an investigational drug or device within 30 days of enrollment, previous participation in a research study with IDP-120 Gel, or participation in a research study concurrent with this study.\n* Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis.\n* Any underlying disease or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion counts inconclusive.\n* Subjects with a facial beard or mustache that could interfere with the study assessments\n* Subjects with more than 2 facial nodules."}, 'identificationModule': {'nctId': 'NCT02850003', 'briefTitle': 'Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Phase 1b Open-Label Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel in Subjects With Acne Vulgaris Under Maximal Use Conditions', 'orgStudyIdInfo': {'id': 'V01-120A-501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDP-120 Gel', 'description': 'Gel', 'interventionNames': ['Drug: IDP-120 Gel']}], 'interventions': [{'name': 'IDP-120 Gel', 'type': 'DRUG', 'otherNames': ['Gel'], 'description': 'Gel', 'armGroupLabels': ['IDP-120 Gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Valeant Site 01', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Anya Loncaric', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Valeant Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}