Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-02-21 @ 10:02 AM
Study NCT ID:
NCT00472966
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2007-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008548', 'term': 'Melanosis'}], 'ancestors': [{'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005446', 'term': 'Fluocinolone Acetonide'}, {'id': 'C031927', 'term': 'hydroquinone'}, {'id': 'D014212', 'term': 'Tretinoin'}, {'id': 'D001483', 'term': 'Base Sequence'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D014801', 'term': 'Vitamin A'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2007-05-10', 'studyFirstSubmitQcDate': '2007-05-11', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Efficacy - Improvement in Investigator's global assessment of melasma", 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Safety - Tolerability assessments and adverse event reporting', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Melasma']}, 'descriptionModule': {'briefSummary': 'To determine the effectiveness and safety of sequential therapy with of Tri-Luma® Cream and a series of Glycolic Acid peels in treatment of moderate to severe melasma.', 'detailedDescription': 'To determine the efficacy and safety of sequential therapy with Fluocinolone acetonide 0.01%, Hydroquinone 4% and Tretinoin 0.05%, and a series of Glycolic Acid peels in the treatment of moderate to severe melasma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects diagnosed with moderate to severe melasma\n\nExclusion Criteria:\n\n* Subjects under treatment for a dermatologic condition, which may interfere with the safe evaluation of the study combination (e.g. eczema, psoriasis, severe sun-damage, dermatitis)\n* Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma) in the areas to be treated'}, 'identificationModule': {'nctId': 'NCT00472966', 'briefTitle': 'Efficacy and Safety of Therapy With Tri-Luma® Cream in Sequence With Glycolic Acid Peels for Melasma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'Open Label Study to Evaluate the Efficacy and Safety of Sequential Therapy With Fluocinolone Acetonide 0.01%, Hydroquinone (HQ) 4% and Tretinoin 0.05% (TriLuma® Cream) and a Series of Glycolic Acid Peels for the Treatment of Melasma', 'orgStudyIdInfo': {'id': 'US10031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels', 'interventionNames': ['Drug: Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels']}], 'interventions': [{'name': 'Fluocinolone acetonide 0.1%/hydroquinone 4%/tretinoin 0.05% Cream in sequence with glycolic acid peels', 'type': 'DRUG', 'otherNames': ['Tri-Luma® Cream', 'NeoStrata® Glycolic Acid Skin Renewal Peel'], 'description': 'Apply cream once daily at night. Subjects will be asked to discontinue use of Fluocinolone acetonide/hydroquinone/tretinoin Cream 2 days prior to the peel and restart 2 days after the peel; Glycolic Acid Peels - In office treatment at weeks 2, 4, 6, 8 and 10', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Skin Care Research, Inc.', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}], 'overallOfficials': [{'name': 'Ronald W Gottschalk, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Galderma R&D'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Ronald W. Gottschalk, MD / Medical Director', 'oldOrganization': 'Galderma Laboratories, L.P.'}}}}