Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT06008327
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2023-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Of Outcome Of Treatment OF Topical 15%TCA VS Topical 0.05% Tretinoin In Treatment Of Acanthosis Nigricans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000052', 'term': 'Acanthosis Nigricans'}], 'ancestors': [{'id': 'D008548', 'term': 'Melanosis'}, {'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': 'D014238', 'term': 'Trichloroacetic Acid'}, {'id': 'D014212', 'term': 'Tretinoin'}], 'ancestors': [{'id': 'D062845', 'term': 'Chloroacetates'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006843', 'term': 'Hydrocarbons, Chlorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-18', 'studyFirstSubmitDate': '2023-03-22', 'studyFirstSubmitQcDate': '2023-08-18', 'lastUpdatePostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EFFICACY OF TOPICAL 15%TRICHLOROACETIC ACID VERSUS 0.05% TOPICAL TRETINOIN IN ACANTHOSIS NIGRICANS', 'timeFrame': 'It will be assessed upto 02 months', 'description': 'Efficacy will be assessed by taking serials photographs before and after treatment shown efficacy in treating acanthosis nigricans. Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acanthosis Nigricans']}, 'descriptionModule': {'briefSummary': 'Acanthosis nigricans (AN) is a dermatosis with aesthetic implications and is characterized by the focal or diffuse development of a velvety, hyperpigmented cutaneous thickening in intertriginous areas. Trichloroacetic acid (TCA), a superficial chemical exfoliative agent has shown efficacy in treating acanthosis nigricans. Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.', 'detailedDescription': 'Acanthosis nigricans is common, although exact prevalence depends upon the racial makeup of the population studied. Exact pathogenesis is unknown, elevated insulin concentrations result in direct and indirect activation of IGF-1 receptors on keratinocytes and fibroblasts, leading to proliferation. This hyperpigmentation, which has poorly defined borders, usually occurs in skin fold areas symmetrically, such as the back of the neck, axilla and groin, and may rarely involve oral mucosa. The lesions may be related to a wide range of benign conditions and may occur as a paraneoplastic manifestation of various potentially fatal malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will present with acanthosis nigricans as per operational definition will be included in the study.\n\n * Either gender.\n * Age 20-50 years.\n\nExclusion Criteria:\n\nPregnancy.\n\n* Breastfeeding.\n* Patients with history of skin resurfacing by dermabrasion, chemical peels and facial laser within the preceding 9 months.\n* Patients with history of hypersensitivity.\n* Malignant Acanthosis Nigricans.\n* Drug Induced Acanthosis Nigricans.'}, 'identificationModule': {'nctId': 'NCT06008327', 'briefTitle': 'Comparison Of Outcome Of Treatment OF Topical 15%TCA VS Topical 0.05% Tretinoin In Treatment Of Acanthosis Nigricans', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Jinnah Postgraduate Medical Centre'}, 'officialTitle': 'Comparison Of The Outcome Of Treatment Of Topical 15% Trichloroacetic Acid Versus Topical 0.05% Tretinoin In The Treatment Of Acanthosis Nigricans', 'orgStudyIdInfo': {'id': 'NO.F2-81/2022-GENL/254/JPMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A Topical 15% Trichloroacetic acid', 'description': '15 % Trichloroacetic acid (TCA) and 0.05%Tretinoin for 02 months Trichloroacetic acid, a superficial chemical exfoliative agent has shown efficacy in treating acanthosis nigricans. 9-10 Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.', 'interventionNames': ['Drug: Topical 15% Trichloroacetic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Group B Topical 0.05% Tretinoin', 'description': 'Topical tretinoin is the first choice of drug in the treatment of acanthosis nigricans. Despite several therapeutic modalities, acanthosis nigricans (AN) remains a difficult dermatosis to treat.', 'interventionNames': ['Drug: Topical 15% Trichloroacetic acid']}], 'interventions': [{'name': 'Topical 15% Trichloroacetic acid', 'type': 'DRUG', 'otherNames': ['Topical 0.05% Tretinoin'], 'description': 'Recently trichloroacetic acid (TCA), a superficial chemical exfoliative agent has shown efficacy in treating acanthosis nigricans. Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.', 'armGroupLabels': ['Group A Topical 15% Trichloroacetic acid', 'Group B Topical 0.05% Tretinoin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'JPMC', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Parisa Sanawar, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jpmc'}, {'name': 'Nazia Jabeen, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jpmc'}, {'name': 'Fazia Inam, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jpmc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinnah Postgraduate Medical Centre', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Khadijah', 'investigatorAffiliation': 'Jinnah Postgraduate Medical Centre'}}}}