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CTRI Number  CTRI/2023/09/057901 [Registered on: 21/09/2023] Trial Registered Prospectively
Last Modified On: 20/09/2023
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 clinical trial to study the effects of two drugs, metformin lotion and zinc oxide cream in patients with melasma, a type of facial pigmentation 
Scientific Title of Study   A comparative study of safety and efficacy of topical Metformin lotion versus Zinc oxide cream in the treatment of melasma 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrNithyaMS 
Designation  postgraduate student 
Affiliation  chengalpattu govt.medical college 
Address  No: 44 , Floor no: 2 Department of dermatology, Chengalpattu medical college

Kancheepuram
TAMIL NADU
603001
India 
Phone  8289815469  
Fax    
Email  nithya.sarala7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Jayakalyani 
Designation  ASSISTANT PROFESSOR 
Affiliation  chengalpattu govt.medical college 
Address  no: 44 , floor no: 2 DEPARTMENT OF DERMATOLOGY, CHENGALPATTU GOVT. MEDICAL COLLEGE

Kancheepuram
TAMIL NADU
603001
India 
Phone  8921306707  
Fax    
Email  dermcliniccmch@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrNithyaMS 
Designation  postgraduate student 
Affiliation  chengalpattu govt.medical college 
Address  No: 44 , Floor no: 2 Department of Dermatology, Chengalpattu medical college

Kancheepuram
TAMIL NADU
695521
India 
Phone  8289815469  
Fax    
Email  nithya.sarala7@gmail.com  
 
Source of Monetary or Material Support  
Chengalpattu Government medical College 
 
Primary Sponsor  
Name  NITHYAMS 
Address  NO :44 , Floor No :1, Department of Dermatology,Chengalpattu medical college 
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 NITHYAMS  CHENGALPATTU medical college  NO :44 , Floor No :1, Department of Dermatology,Chengalpattu medical college
Kancheepuram
TAMIL NADU 		 8289815469

nithya.sarala7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chengalpattu institute ethical committee  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  30% Metformin lotion at night for 2 months  patients are asked to apply 30% metformin lotion at night over melasma for 2 months 
Comparator Agent  topical zinc oxide cream bd for 2 months  patients are asked to apply zinc oxide cream twice daily over melasma for2 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of both genders above 18 years who were clinically diagnosed to have melasma
2.Patients willing to give a written informed consent
 
 
ExclusionCriteria 
Details 
Before starting the study

1. Pregnant & lactating mothers
2. Patients on oral contraceptives, phenytoin
3. Patients with unrealistic expectations
4. Patients who are allergic to metformin
5. Patients on medications for melasma since at least 2 weeks for topical therapy, 1 month for systemic steroids, 3 months for cosmetic procedures such as laser, dermabrasion, or peels
6. Patients with co-morbidities-DM, SHTN, TB,CAD,EPILEPSY,BA, carcinomas, Renal dysfunction,

During Study
1. If patient develops side effects during the treatment
2. If patient wants alternate treatment during the study.
3. If patient wants to discontinue the treatment. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in intensity of pigmentation   8 weeks after using medication 
 
Secondary Outcome  
Outcome  TimePoints 
Prevention of relapse   1 year 
 
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 2/ Phase 3 
Date of First Enrollment (India)   01/10/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Melasma is a common, acquired disorder of melanogenesis leading to hyperpigmentation and characterized by irregular symmetrical brown to gray-black macules on the face.Melasma management is difficult because of its frequent relapse. The first thing to do is to eliminate risk factors if possible and to avoid exposure from the sun.

 

 Recently, studies have shown that topical metformin has melanopenic action, which is due to downregulation of the expression of MITF which in turn leads to downregulation of transcription of various melanogenic proteins such as tyrosinase, TRP‐1, TRP‐2, and protein kinase C‐beta

Hence, this study was undertaken to evaluate the safety and efficacy of topical metformin in melasma.


 
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