| CTRI Number |
CTRI/2026/02/105051 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Microneedling with Metformin Cream and Microneedling with Glutathione Cream in Reducing Dark Facial Patches (Melasma) in Adult |
|
Scientific Title of Study
|
A Study On Efficacy Of Microneedling With Topical Metformin Versus Microneedling With Topical Glutathione In Treatment Of Melasma A Randomized Controlled Study |
| 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 Yashaswini G S |
| Designation |
Junior resident of dermatology |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Room no.26,Department of Dermatology RL Jalappa Hospital Sri Devaraj Urs Medical College Tamaka Kolar
Kolar
KARNATAKA
563103
India |
| Phone |
07795885226 |
| Fax |
|
| Email |
yashaswinisrinivas03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RAJASHEKAR T S |
| Designation |
Professor and Head of Department,Department of Dermatology,Sri Devaraj Urs Medical College |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Room no.26,Department of Dermatology RL Jalappa Hospital Sri Devaraj Urs Medical College Tamaka Kolar
Kolar
KARNATAKA
563103
India |
| Phone |
9448316136 |
| Fax |
|
| Email |
Rajashekardermat@sduaher.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashaswini G S |
| Designation |
Junior resident of dermatology |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Room no.26,Department of Dermatology RL Jalappa Hospital Sri Devaraj Urs Medical College Tamaka Kolar
Kolar
KARNATAKA
563103
India |
| Phone |
7795885226 |
| Fax |
|
| Email |
yashaswinisrinivas03@gmail.com |
|
|
Source of Monetary or Material Support
|
| R L Jalappa Hospital, Sri Devaraj Urs Medical College, Tamaka, Kolar,karnataka,India 563103 |
|
|
Primary Sponsor
|
| Name |
Dr YASHASWINI G S |
| Address |
Sri Devaraj Urs Medical College,Tamaka,Kolar,Karnataka-563103 |
| Type of Sponsor |
Other [self] |
|
|
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 Yashaswini G S |
Sri Devaraj Urs Medical College,R L Jalappa Hospital |
Room no.26,Department of Dermatology,RL Jalappa Hospital Sri Devaraj Urs Medical College Tamaka Kolar
Kolar
KARNATAKA |
7795885226
yashaswinisrinivas03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DEVARAJ URS MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L811||Chloasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Microneedling With Topical Glutathione |
Topical glutathione six hundred milligrams applied over the microneedled facial melasma areas
Topical application immediately after each microneedling session via transdermal route on facial lesions
Total duration: Sessions repeated at an interval of one month for a maximum of eight sessions that is around eight months, same schedule as intervention arm |
| Intervention |
Microneedling With Topical Metformin |
Topical metformin cream containing metformin hydrochloride fifteen grams in one hundred grams of cream base liquid paraffin twenty five grams beeswax twelve grams borax zero point eight grams methyl paraben zero point two grams purified water approximately forty seven grams applied over treated facial melasma areas after microneedling
Topical application immediately after each microneedling session via transdermal route on facial lesions
Sessions repeated at an interval of one month for a maximum of eight sessions that is around eight months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Female patients aged twenty to fifty years with clinically diagnosed facial melasma Fitzpatrick skin type three or four willing to give informed consent and comply with study protocol and not receiving any melasma treatment for at least three months prior to enrollment |
|
| ExclusionCriteria |
| Details |
Patients who are pregnant or breastfeeding
Females with PCOD
Smokers
Active hormonal therapy
Consumption of antioxidants in last Three months
Use of isotretinoin in past six months
Active inflammatory acne lesions
Drugs causing photosensitivity and hyperpigmentation as epileptic drugs
Antimilaria and tetracycline
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in modified Melasma Area And Severity Index score from baseline to the end of treatment in each group and comparison of mean percentage reduction in modified Melasma Area And Severity Index between microneedling with topical metformin and microneedling with topical glutathione |
4 weeks & 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Global Photographic Assessment score & documentation of treatment related adverse effects & patient satisfaction in both groups |
4 weeks & 8 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
07/03/2026 |
| 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="1"
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
|
This randomized parallel group clinical trial will evaluate the efficacy and safety of microneedling with topical metformin compared to microneedling with topical glutathione in adult female patients with facial melasma. Sixty participants will be allocated into two equal groups and receive eight monthly treatment sessions. Clinical improvement will be assessed using modified Melasma Area And Severity Index scores and a global photographic assessment scale, along with documentation of adverse effects and patient satisfaction. The study aims to identify which microneedling assisted topical therapy provides greater pigmentation reduction and better tolerability, thereby offering an effective and affordable option for melasma management. |