Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-25 @ 1:47 PM
Study NCT ID:
NCT00166192
Status:
COMPLETED
Last Update Posted:
2013-11-14
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-12', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2013-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Clinical efficacy by clinician's evaluation", 'timeFrame': '3 months', 'description': 'Hyperpigmenation Global Score'}], 'secondaryOutcomes': [{'measure': "Efficacy by subject's evaluation", 'timeFrame': '3 months', 'description': 'Hyperpigmentation Global Score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Melasma', "Jessner's solution", 'Trichloroacetic acid (TCA)'], 'conditions': ['Melasma']}, 'descriptionModule': {'briefSummary': "Melasma is an acquired discoloration of the skin characterized by brown patches. Chemical peels using agents such as Jessner's solution and trichloroacetic acid (TCA) are commonly used to treat melasma. A chemical peel involves applying the peeling agent to the skin for a short period. The skin will peel similar to a sunburn, and moisturizers are applied to the skin. Although both agents are well-accepted, there have been no good comparisons of the two agents. The purpose of this study is determine if there is a difference in the effectiveness of these two agents."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults \\> 18 years old\n* Clinical diagnosis of melasma\n* Mental capacity to give informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* H/o allergy to Jessner's solution, tricholoracetetic acid, tretinoin, or hydroquinone\n* Active dermatitis\n* Presence of cutaneous infection"}, 'identificationModule': {'nctId': 'NCT00166192', 'briefTitle': "Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid", 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': "Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid: A Comparison of Clinical Efficacy", 'orgStudyIdInfo': {'id': 'IRB00024850'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Chemical Peel', 'description': 'Split face treatment paradigm', 'interventionNames': ["Procedure: Jessner's solution chemical peel", 'Procedure: Trichloroacetic acid chemical peel']}], 'interventions': [{'name': "Jessner's solution chemical peel", 'type': 'PROCEDURE', 'armGroupLabels': ['Chemical Peel']}, {'name': 'Trichloroacetic acid chemical peel', 'type': 'PROCEDURE', 'armGroupLabels': ['Chemical Peel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Dermatology Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Carl Washington, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University Department of Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zakiya Rice', 'investigatorAffiliation': 'Emory University'}}}}