Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-06-05 @ 10:07 AM
Study NCT ID:
NCT03094403
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2017-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010038', 'term': 'azelaic acid'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects in this randomized, double-blind, placebo controlled, parallel-group, multiple-center study will be randomly assigned in a 2:2:1 ratio to treatment with the test product, reference product or placebo control, respectively'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2017-03-17', 'studyFirstSubmitQcDate': '2017-03-23', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in inflammatory lesion counts', 'timeFrame': '12 weeks', 'description': 'Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rosacea']}, 'descriptionModule': {'briefSummary': 'A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study', 'detailedDescription': 'A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, comparing AZELAIC ACID TOPICAL GEL 15% TO FINACEA® and both active treatments to a Placebo Control in the treatment of Moderate of Facial Rosacea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or non-pregnant female ≥ 18 years-of-age with a clinical diagnosis of moderate facial rosacea;\n* Subjects had to have a definite clinical diagnosis of facial rosacea severity Grade 3 as per the IGE\n\nExclusion Criteria:\n\n* Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;'}, 'identificationModule': {'nctId': 'NCT03094403', 'briefTitle': 'To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries, Inc.'}, 'officialTitle': 'A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Azeliac Acid Gel and Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea.', 'orgStudyIdInfo': {'id': 'AZAG 1533'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azelaic Acid 15% topical gel', 'description': 'Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face', 'interventionNames': ['Drug: Azelaic Acid 15% topical gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Finacea® (azelaic acid) Gel, 15%', 'description': 'Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face', 'interventionNames': ['Drug: Finacea® (azelaic acid) Gel, 15%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Topically to the face, twice a day A thin layer of study treatment was gently massaged into the affected areas on the face', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Azelaic Acid 15% topical gel', 'type': 'DRUG', 'otherNames': ['Azelaic Acid'], 'description': 'Gel', 'armGroupLabels': ['Azelaic Acid 15% topical gel']}, {'name': 'Finacea® (azelaic acid) Gel, 15%', 'type': 'DRUG', 'otherNames': ['Azelaic Acid'], 'description': 'Gel', 'armGroupLabels': ['Finacea® (azelaic acid) Gel, 15%']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'Gel', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Catawba Research', 'role': 'STUDY_CHAIR', 'affiliation': 'http://catawbaresearch.com/contact/'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}