Comparison Of Outcome Of Treatment OF Topical 15%TCA VS Topical 0.05% Tretinoin In Treatment Of Acanthosis Nigricans

NCT ID: NCT06008327

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-06-20

Brief Summary

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.

Detailed Description

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.

Conditions

Acanthosis Nigricans

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A Topical 15% Trichloroacetic acid

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.

Group Type: EXPERIMENTAL

Topical 15% Trichloroacetic acid

Intervention Type: DRUG

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.

Group B Topical 0.05% Tretinoin

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.

Group Type: EXPERIMENTAL

Topical 15% Trichloroacetic acid

Intervention Type: DRUG

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.

Interventions

Topical 15% Trichloroacetic acid

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.

Intervention Type: DRUG

Other Intervention Names

Topical 0.05% Tretinoin

Eligibility Criteria

Inclusion Criteria

• Patients who will present with acanthosis nigricans as per operational definition will be included in the study.

• Either gender.
• Age 20-50 years.

Exclusion Criteria

Pregnancy.

• Breastfeeding.
• Patients with history of skin resurfacing by dermabrasion, chemical peels and facial laser within the preceding 9 months.
• Patients with history of hypersensitivity.
• Malignant Acanthosis Nigricans.
• Drug Induced Acanthosis Nigricans.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jinnah Postgraduate Medical Centre

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr Khadijah

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Parisa Sanawar, FCPS

Role: PRINCIPAL_INVESTIGATOR

Jpmc

Nazia Jabeen, FCPS

Role: PRINCIPAL_INVESTIGATOR

Jpmc

Fazia Inam, FCPS

Role: PRINCIPAL_INVESTIGATOR

Jpmc

Locations

JPMC

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

NO.F2-81/2022-GENL/254/JPMC

Identifier Type: -

Identifier Source: org_study_id