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CTRI Number  CTRI/2025/10/096111 [Registered on: 15/10/2025] Trial Registered Prospectively
Last Modified On: 15/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparing Glycolic Acid Peel and Cream for treating Melasma 
Scientific Title of Study   Effectiveness of Fortnightly 35 percent Glycolic Acid Peel Versus Daily 12 percent Glycolic Acid Cream in the Treatment of Melasma: A Prospective, Comparative, Two-arm, Double-blind, Randomised Controlled Study at a Tertiary Care Centre in Mandya 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shashikumar B M 
Designation  Associate Professor and Head of the Department 
Affiliation  Mandya institute of medical sciences 
Address  OPD Number 13, 1st floor, Department of Dermatology, Mandya institute of medical sciences, Mandya

Mandya
KARNATAKA
571401
India 
Phone  9886197902  
Fax    
Email  shashikumarbm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepadarshan K  
Designation  Assistant Professor  
Affiliation  Mandya institute of medical sciences 
Address  OPD Number 13, 1st floor, Department of Dermatology, Mandya institute of medical sciences, Mandya

Mandya
KARNATAKA
571401
India 
Phone  9844861596  
Fax    
Email  deepadarshan.rani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepadarshan K  
Designation  Assistant Professor  
Affiliation  Mandya institute of medical sciences 
Address  OPD Number 13, 1st floor, Department of Dermatology, Mandya institute of medical sciences, Mandya

Mandya
KARNATAKA
571401
India 
Phone  9844861596  
Fax    
Email  deepadarshan.rani@gmail.com  
 
Source of Monetary or Material Support  
Mandya Institute of Medical Sciences, Bengaluru - Mysore main road, Mandya, 571401 
 
Primary Sponsor  
Name  Dr Shashikumar B M 
Address  OPD no 13, Department of Dermatology, Venereology and Leprosy, MIMS, Mandya 
Type of Sponsor  Other [Self ] 
 
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 Deepadarshan K  MANDYA INSTITUTE OF MEDICAL SCIENCES  OPD Number 13, 1st floor, Department of Dermatology, Mandya institute of medical sciences, Mandya
Mandya
KARNATAKA 		 9844861596

deepadarshan.rani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee, MIMS , Mandya  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L811||Chloasma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  12% Glycolic acid cream  The comparator agent in this study is Glycolic Acid 12 percent (w/w) cream, an Alpha Hydroxy Acid (AHA) topical formulation applied daily at night to the affected areas of the face as instructed. Patients in Group B receive this cream along with a placebo peel to ensure blinding of both investigator and patient. The treatment is continued consistently for 12 weeks. The expected therapeutic effect of the cream is to provide mild daily exfoliation, gradually reduce pigmentation through removal of melanin, improve skin tone and texture, and promote epidermal regeneration, thereby serving as a comparative modality against the stronger glycolic acid peel. 
Intervention  35 percent Glycolic acid peel   The intervention agent in this study is Glycolic Acid 35 percent (w/v) peel, an Alpha Hydroxy Acid (AHA) chemical peel administered every two weeks under dermatologist supervision. It is applied as a facial peel, with the face divided into anatomic units such as the forehead, cheeks, nose, glabella, and perioral area. After degreasing, the peel is applied for 20–30 seconds initially and then left for about five minutes before being neutralized with distilled water. The treatment is continued for 12 weeks, comprising a total of six sittings. Participants in Group A receive this glycolic acid 35% peel along with a placebo cream, with both the investigator and patient blinded to group allocation. The expected therapeutic effect of the peel is controlled epidermal dyscohesion, which facilitates removal of epidermal melanin, reduces melanosome transfer, and promotes epidermal regeneration, thereby improving pigmentation in melasma. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients diagnosed with melasma.
Patients aged 18-65 years of both sexes.
Patients who are not on active treatment and not taken any treatment for melasma in the past 1 month.
Patients willing to give informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  Pregnant and lactating females.
Hypersensitivity to the peeling agent.
Skin infection at the site of Melasma (herpes, pyoderma, and folliculitis).
Patients with topical steroid damaged face.
Patients with rosacea, systemic lupus erythematosus and other photodermatoses.
Patients consuming Oral contraceptive pills.
Patients with unrealistic expectations.
Patients consuming Isotretinoin tablets and other drug which can cause and exuberate melasma.
History of keloids or hypertrophic scars.
Concomitant skin or systemic disease.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
• Change in MASI (Melasma Area and Severity Index) score.   • From baseline( Day 0) to 4, 8, and 12 weeks.  
 
Secondary Outcome  
Outcome  TimePoints 
Grading of subjective improvement in pigmentation, assessed as no response, mild, moderate, good, or very good response based on MASI score reduction.  Before treatment and at the completion of the study (end of 12 weeks, after the sixth peel/last follow-up visit) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   27/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shashikumarbm@gmail.com].

  6. For how long will this data be available start date provided 10-10-2025 and end date provided 10-07-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is a prospective hospital-based, double-blind, randomized controlled trial designed to compare the efficacy of fortnightly 35% glycolic acid peel with daily 12% glycolic acid cream in the treatment of melasma. A total of 60 patients aged 18–65 years will be randomized into two groups of 30 each: Group A will receive 35% glycolic acid peels every two weeks along with a placebo cream, while Group B will receive daily 12% glycolic acid cream with a placebo peel. Both patients and investigators will remain blinded to the treatment allocation, with placebos used to maintain blinding. All participants will be advised regular use of sunscreen. The primary objective is to evaluate and compare the reduction in pigmentation using the Melasma Area and Severity Index (MASI) score at baseline, 4, 8, and 12 weeks. Secondary objectives include assessing the impact of treatment on quality of life, recording adverse events, and comparing efficacy across different melasma types (epidermal, dermal, mixed). By directly comparing peel versus cream therapy, this study aims to provide valuable evidence on which modality offers better clinical outcomes, safety, and cost-effectiveness, thereby guiding dermatologists in optimizing melasma management. 
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