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

Sponsor
Jinnah Postgraduate Medical Centre (Other)
Overall Status
Completed
CT.gov ID
NCT06008327
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
10.6
Actual Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Topical 15% Trichloroacetic acid
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison Of The Outcome Of Treatment Of Topical 15% Trichloroacetic Acid Versus Topical 0.05% Tretinoin In The Treatment Of Acanthosis Nigricans
Actual Study Start Date :
Aug 1, 2022
Actual Primary Completion Date :
Jun 20, 2023
Actual Study Completion Date :
Jun 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: 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.
Other Names:
  • Topical 0.05% Tretinoin

    		•
    Experimental: 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.

    Drug: 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.
    Other Names:
  • Topical 0.05% Tretinoin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 JPMC Karachi Sindh Pakistan

    Sponsors and Collaborators

    • Jinnah Postgraduate Medical Centre

    Investigators

    • Principal Investigator: Parisa Sanawar, FCPS, Jpmc
    • Principal Investigator: Nazia Jabeen, FCPS, Jpmc
    • Principal Investigator: Fazia Inam, FCPS, Jpmc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Khadijah, Principal Investigator, Jinnah Postgraduate Medical Centre
    ClinicalTrials.gov Identifier:
    NCT06008327
    Other Study ID Numbers:
    • NO.F2-81/2022-GENL/254/JPMC
    First Posted:
    Aug 23, 2023
    Last Update Posted:
    Aug 23, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acanthosis Nigricans
    Tretinoin

    Study Results

    No Results Posted as of Aug 23, 2023