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

Phase 2/3

Not yet recruiting

• Conditions: Chloasma,

• Registration Number: CTRI/2023/09/057901
• Lead Sponsor: NITHYAMS

Brief Summary

Melasmais a common, acquired disorder of melanogenesis leading to hyperpigmentationand characterized by irregular symmetrical brown to gray-black macules on theface.Melasmamanagement is difficult because of its frequent relapse. The first thing to dois to eliminate risk factors if possible and to avoid exposure from the sun.

Recently, studieshave shown that topical metformin has melanopenic action, which is due todownregulation of the expression of MITF which in turn leads to downregulationof transcription of various melanogenic proteins such as tyrosinase, TRPâ€1,TRPâ€2, and protein kinase Câ€beta

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-10
• Last Update Posted: 2023-09-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Patients of both genders above 18 years who were clinically diagnosed to have melasma 2.Patients willing to give a written informed consent.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in intensity of pigmentation	8 weeks after using medication

Secondary Outcome Measures

Name	Time	Method
Prevention of relapse	1 year

Trial Locations

Locations (1)

CHENGALPATTU medical college; 🇮🇳 Kancheepuram, TAMIL NADU, India

CHENGALPATTU medical college

🇮🇳Kancheepuram, TAMIL NADU, India

Dr NITHYAMS

Principal investigator

8289815469

nithya.sarala7@gmail.com