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

Not Applicable

Completed

• Conditions: Acanthosis Nigricans
• Interventions: Drug: Topical 15% Trichloroacetic acid

• Registration Number: NCT06008327
• Lead Sponsor: Jinnah Postgraduate Medical Centre

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.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2023-03-22
• Primary Completion: 2023-06-20
• Study Completion: 2023-06-20
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-18
• Last Update Submitted: 2023-08-18
• Study First Posted: 2023-08-23
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A Topical 15% Trichloroacetic acid	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 B Topical 0.05% Tretinoin	Topical 15% Trichloroacetic acid	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.

Primary Outcome Measures

Name	Time	Method
EFFICACY OF TOPICAL 15%TRICHLOROACETIC ACID VERSUS 0.05% TOPICAL TRETINOIN IN ACANTHOSIS NIGRICANS	It will be assessed upto 02 months	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.

Trial Locations

Locations (1)

JPMC; 🇵🇰 Karachi, Sindh, Pakistan