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CTRI Number  CTRI/2025/02/080911 [Registered on: 19/02/2025] Trial Registered Prospectively
Last Modified On: 18/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to demonstrate the safety and efficacy of oral metformin in treatment of melasma in Indian population. 
Scientific Title of Study   An assessor blinded, randomized controlled trial comparing the safety and efficacy of oral metformin with topical 4 percent hydroquinone vs topical 4 percent hydroquinone alone in treatment of melasma in Indian skin types. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G Manoj Pavan Reddy 
Designation  Junior Resident Acad 
Affiliation  All India Institiute of Medical Sciences, New Delhi 
Address  Room no. 4070, Fourth floor, Department of Dermatology & Venereology, Academic block, Near JLN auditorium, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9182417019  
Fax    
Email  manojpavan1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sethuraman Gomathy 
Designation  Professor 
Affiliation  All India Institiute of Medical Sciences, New Delhi 
Address  Room no. 4068, Fourth floor, Department of Dermatology & Venereology, Academic block, Near JLN auditorium, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9871744538  
Fax    
Email  aiimsgsr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr G Manoj Pavan Reddy 
Designation  Junior Resident Acad 
Affiliation  All India Institiute of Medical Sciences, New Delhi 
Address  Room no. 4070, Fourth floor, Department of Dermatology & Venereology, Academic block, Near JLN auditorium, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9182417019  
Fax    
Email  manojpavan1999@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, India, 110029. 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, New Delhi 
Address  Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
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 G Manoj Pavan Reddy  All India Institute of Medical Sciences, New Delhi  Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI 		 9182417019

manojpavan1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee All India Institute of Medical Sciences  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 
Intervention  Systemic metformin, topical 4% hydroquinone and sunscreen 30 SPF  Tab metformin 500mg 2 tabs per oral after breakfast daily for 3 months, topical 4% hydroquinone local application as a thin layer of the cream on the melasma patches over face once daily at night and sunscreen 30 SPF to be applied thrice daily (9 am, 11 am and 3 pm) on the face. 
Comparator Agent  Topical 4% hydroquinone and sunscreen 30 SPF  Topical 4% hydroquinone local application as a thin layer of the cream on the melasma patches over face once daily at night and sunscreen 30 SPF to be applied thrice daily (9 am, 11 am and 3 pm) on the face. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age group more than or equal to 18 years
Patients with clinical diagnosis of melasma
Patients who have not received any prior medical treatment for melasma or with a wash out period of 6 weeks for any previous treatment.
Patients with moderate (mMASI 5.8 to 7.9) to severe Melasma (mMASI more than 7.9).
 
 
ExclusionCriteria 
Details  Age group less than 18 years
Pregnant or lactating females
Patients on medications like oral contraceptives, hormone replacement therapy
Patients with any current skin infections on the face.
Diabetic patients
Any contraindications to oral metformin
- Impaired renal function (serum creatinine more than 1.5 mg/dl in men and more than 1.4 mg/dl in women)
- NYHA grade 3 or grade 4 heart failure
- Acute or chronic metabolic acidosis

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in mean MASI in both the groups  at the end of 3 months of intervention and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in mean MELASQoL in both the groups  at the end of 3 months of intervention & 6 months 
Change in mean Melanin Index in both the groups  at the end of 3 months of intervention & 6 months 
Photographic improvement in both the groups with physician global assessment  at the end of 3 months of intervention & 6 months 
Adverse reactions in both groups  monthly till the end of intervention period at 3 months  
Difference in the patient satisfaction score with the treatment in between the groups  at the end of intervention period at 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/03/2025 
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="2"
Months="0"
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   This study is an assessor blinded, randomized controlled trial comparing the safety and efficacy of oral metformin with topical 4% hydroquinone vs topical 4% hydroquinone alone in treatment of melasma in Indian skin types that will be conducted at AIIMS, New Delhi. The primary outcome measure is the change in the mean MASI of both the groups at the end of 3 months of intervention and 6 months. The secondary outcome measures will be change in mean MELASQoL, change in mean Melanin index, photographic improvement using physician global assessment in both the groups at the end of 3 months of intervention and 6 months; adverse reactions in both the groups at monthly follow up till 3 months, difference in the patient satisfaction score with the treatment in between the groups at the end of intervention period at 3 months. 
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