search
Back to results

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

Primary Purpose

Acanthosis Nigricans

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Topical 15% Trichloroacetic acid
Sponsored by
Jinnah Postgraduate Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acanthosis Nigricans

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • JPMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A Topical 15% Trichloroacetic acid

Group B Topical 0.05% Tretinoin

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2023
Last Updated
August 18, 2023
Sponsor
Jinnah Postgraduate Medical Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT06008327
Brief Title
Comparison Of Outcome Of Treatment OF Topical 15%TCA VS Topical 0.05% Tretinoin In Treatment Of Acanthosis Nigricans
Official Title
Comparison Of The Outcome Of Treatment Of Topical 15% Trichloroacetic Acid Versus Topical 0.05% Tretinoin In The Treatment Of Acanthosis Nigricans
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
June 20, 2023 (Actual)
Study Completion Date
June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinnah Postgraduate Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acanthosis Nigricans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A Topical 15% Trichloroacetic acid
Arm Type
Experimental
Arm 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.
Arm Title
Group B Topical 0.05% Tretinoin
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Topical 15% Trichloroacetic acid
Other Intervention Name(s)
Topical 0.05% Tretinoin
Intervention 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.
Primary Outcome Measure Information:
Title
EFFICACY OF TOPICAL 15%TRICHLOROACETIC ACID VERSUS 0.05% TOPICAL TRETINOIN IN ACANTHOSIS NIGRICANS
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.
Time Frame
It will be assessed upto 02 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parisa Sanawar, FCPS
Organizational Affiliation
Jpmc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nazia Jabeen, FCPS
Organizational Affiliation
Jpmc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fazia Inam, FCPS
Organizational Affiliation
Jpmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
JPMC
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs