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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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