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CompletedNCT06008327Updated Aug 23, 2023

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

An interventional study of Topical 15% Trichloroacetic acid in Acanthosis Nigricans, sponsored by Jinnah Postgraduate Medical Centre. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-23.

Sponsored by Jinnah Postgraduate Medical Centre · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Aug 2022, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acanthosis Nigricans
03

In context

Lead sponsor

Jinnah Postgraduate Medical Centre is the lead sponsor of 38 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugTopical 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.

    Also known as: Topical 0.05% Tretinoin

06

What researchers measure

Primary outcomes

  1. EFFICACY OF TOPICAL 15%TRICHLOROACETIC ACID VERSUS 0.05% TOPICAL TRETINOIN IN ACANTHOSIS NIGRICANS

    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.

    Time frame: It will be assessed upto 02 months

07

Study locations

1 site
  • JPMC
    Karachi, Sindh, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06008327
Lead sponsor
Jinnah Postgraduate Medical Centre
Responsible party
Dr Khadijah (Principal Investigator, Jinnah Postgraduate Medical Centre) — Principal investigator
First posted
Aug 23, 2023
Start date
Aug 1, 2022
Primary completion
Jun 20, 2023
Completion
Jun 20, 2023
Last update
Aug 23, 2023

Study contacts

Parisa Sanawar, FCPS
principal investigator · Jpmc
Nazia Jabeen, FCPS
principal investigator · Jpmc
Fazia Inam, FCPS
principal investigator · Jpmc

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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