Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT02601703
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2015-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2015-11-09', 'studyFirstSubmitQcDate': '2015-11-09', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment", 'timeFrame': 'Day 15'}], 'secondaryOutcomes': [{'measure': 'The change in severity score from baseline to study Day 15 of the four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification and pruritus).', 'timeFrame': 'Day 15'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Non-immunocompromised male or non-pregnant, non-lactating female, 18 years of age or older with a clinical diagnosis of moderate to severe AD.\n2. Have confirmed diagnosis of atopic dermatitis for at least 3 months using the diagnostic features as described by Hanifin and Rajka\n3. Have an IGA score of 3 (moderate) or 4 (severe).\n4. Have an affected Body Surface Area (BSA) of at least 20% at baseline.\n5. Treated with a bland emollient for at least 7 days.\n\nKey Exclusion Criteria:\n\n1. Active cutaneous bacterial or viral infection in any treatment area at baseline.\n2. Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline.\n3. History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.\n4. History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders.\n5. Known allergy or hypersensitivity to tacrolimus or any other component of the Study products."}, 'identificationModule': {'nctId': 'NCT02601703', 'briefTitle': 'To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glenmark Pharmaceuticals Ltd. India'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (Tacrolimus) Ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD)', 'orgStudyIdInfo': {'id': 'GLK-1501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tacrolimus Ointment 0.1%', 'interventionNames': ['Drug: Tacrolimus Ointment 0.1%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Protopic® ointment, 0.1%', 'interventionNames': ['Drug: Protopic® ointment, 0.1%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of Tacrolimus Ointment', 'interventionNames': ['Drug: Placebo of Tacrolimus Ointment']}], 'interventions': [{'name': 'Tacrolimus Ointment 0.1%', 'type': 'DRUG', 'description': 'apply thin layer of ointment to affected area', 'armGroupLabels': ['Tacrolimus Ointment 0.1%']}, {'name': 'Protopic® ointment, 0.1%', 'type': 'DRUG', 'description': 'apply thin layer of ointment to affected area', 'armGroupLabels': ['Protopic® ointment, 0.1%']}, {'name': 'Placebo of Tacrolimus Ointment', 'type': 'DRUG', 'description': 'apply thin layer of ointment to affected area', 'armGroupLabels': ['Placebo of Tacrolimus Ointment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Glenmark Investigational Site 49', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 31', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Bell Gardens', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 23', 'geoPoint': {'lat': 33.96529, 'lon': -118.15146}}, {'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 30', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 15', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 14', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 1', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 17', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 25', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'city': 'San Ramon', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 20', 'geoPoint': {'lat': 37.77993, 'lon': -121.97802}}, {'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Glenmark Investigational Site 44', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'city': 'Brooksville', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 45', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 43', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 34', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 22', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 35', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'city': 'Hialeah Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 59', 'geoPoint': {'lat': 25.8651, 'lon': -80.3245}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 11', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 19', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 33', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 40', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 42', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 50', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 51', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 54', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 56', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 58', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site7', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 28', 'geoPoint': {'lat': 25.94204, 'lon': -80.2456}}, {'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 29', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 18', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'city': 'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 32', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 48', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 4', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 47', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Glenmark Investigational Site 5', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Glenmark Investigational Site 52', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'city': 'Madisonville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Glenmark Investigational Site12', 'geoPoint': {'lat': 37.3281, 'lon': -87.49889}}, {'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'Glenmark Investigational Site 2', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Glenmark Investigational Site 41', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Glenmark Investigational Site 16', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Glenmark Investigational Site 9', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Glenmark Investigational Site 46', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Glenmark Investigational Site 53', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Glenmark Investigational Site 21', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Glenmark Investigational Site 36', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'city': 'Hazleton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Glenmark Investigational Site 3', 'geoPoint': {'lat': 40.95842, 'lon': -75.97465}}, {'city': 'West Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Glenmark Investigational Site 57', 'geoPoint': {'lat': 33.99349, 'lon': -81.07398}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Glenmark Investigational Site 6', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Baytown', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 60', 'geoPoint': {'lat': 29.7355, 'lon': -94.97743}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 27', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 39', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 8', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Lampasas', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 24', 'geoPoint': {'lat': 31.06378, 'lon': -98.1817}}, {'city': 'Missouri City', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 37', 'geoPoint': {'lat': 29.61857, 'lon': -95.53772}}, {'city': 'Pflugerville', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 10', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 13', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 26', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 55', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Glenmark Investigational Site 38', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}], 'overallOfficials': [{'name': 'Dr. Nikhil Sawant', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glenmark Pharmaceuticals Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glenmark Pharmaceuticals Ltd. India', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}