| CTRI Number |
CTRI/2025/09/094913 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Chemical peels ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Trichloroacetic Acid Peel and Glycolic Acid Peel in the Treatment of Acanthosis Nigricans |
|
Scientific Title of Study
|
Efficacy of 15% Trichloroacetic Acid Peel versus 35% Glycolic Acid Peel in Acanthosis Nigricans – At a Tertiary Care Center in Central Karnataka |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwini K Ajjewadermath |
| Designation |
Junior resident |
| Affiliation |
JJM Medical College |
| Address |
Department of Dermatology, room no 9
JJM Medical College, MCC B block, davangere
Davanagere KARNATAKA 577004 India |
| Phone |
7090317504 |
| Fax |
|
| Email |
ashwinika95@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr MANGALA H C |
| Designation |
Professor |
| Affiliation |
JJM Medical College |
| Address |
Department of dermatology, room no 9, JJM medical college, MCC B block, Davangere
Davanagere KARNATAKA 577004 India |
| Phone |
9886075467 |
| Fax |
|
| Email |
drhcmangala@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashwini K Ajjewadermath |
| Designation |
Junior resident |
| Affiliation |
JJM Medical College |
| Address |
Department of dermatology, room no 9, JJM Medical college, MCC B block, Davangere
Davanagere KARNATAKA 577004 India |
| Phone |
7090317504 |
| Fax |
|
| Email |
ashwinika95@gmail.com |
|
|
Source of Monetary or Material Support
|
| JJM MEDICAL COLLEGE, Davangere |
|
|
Primary Sponsor
|
| Name |
JJM MEDICAL COLLEGE |
| Address |
MCC B Block, Kuvempu Nagar, Davanagere, Karnataka 577004 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashwini K Ajjewadermath |
JJM MEDICAL COLLEGE |
Department of Dermatology, room no 9, JJM Medical College, MCC B Block, Kuvempu Nagar, Davanagere, Karnataka 577004 Davanagere KARNATAKA |
7090317504
ashwinika95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JJM Medical College, Davangere |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Acanthosis Nigricans |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
15% Trichloroacetic acid peel |
15% Trichloroacetic acid peel applied at 2-weekly intervals for 6 sessions over affected areas of acanthosis nigricans. |
| Comparator Agent |
35% Glycolic Acid Peel |
35% Glycolic acid peel applied at 2-weekly intervals for 6 sessions over affected areas of acanthosis nigricans. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All adults 18 years and older with a clinical diagnosis of AN affecting the face, neck, or elbow, or any combination of these three, who presented to the dermatology outpatient department and are willing to give consent |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating females.
Hypersensitivity to the peeling agent.
Skin infection at the site of AN (herpes, pyoderma, and folliculitis).
Individuals prone to keloid formation.
History of any topical application in the last 4 weeks |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in severity of acanthosis nigricans as assessed by Acanthosis Nigricans Severity Index (ANSI) score |
At baseline, 2,4,6 and 8 weeks after initiation of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction assessed by Visual Analogue Scale (VAS). |
At 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acanthosis nigricans is a common skin condition characterized by hyperpigmented and velvety thickened plaques, most often associated with obesity and insulin resistance. Chemical peels are frequently used to improve pigmentation and texture in such patients. This randomized, prospective, single center clinical trial is designed to compare the efficacy and safety of fifteen percent trichloroacetic acid peel with thirty five percent glycolic acid peel in patients with acanthosis nigricans. Eligible patients will be randomly allocated into two groups to receive either trichloroacetic acid peel or glycolic acid peel at regular intervals. Improvement will be assessed using validated pigmentation scores and patient satisfaction at baseline and at follow up visits. The primary outcome will be reduction in pigmentation, while secondary outcomes include improvement in skin texture and assessment of adverse effects. The findings of this study are expected to provide evidence regarding the relative effectiveness of two commonly used chemical peels in the management of acanthosis nigricans.
|