A study to demonstrate the safety and efficacy of oral metformin in treatment of melasma in Indian population.

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. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080911

Enrollment

Registered

2025-02-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L811- Chloasma

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Change in mean MASI in both the groupsTimepoint: at the end of 3 months of intervention and 6 months	—

Secondary

Measure	Time frame
Change in mean MELASQoL in both the groupsTimepoint: at the end of 3 months of intervention & 6 months;Change in mean Melanin Index in both the groupsTimepoint: at the end of 3 months of intervention & 6 months;Photographic improvement in both the groups with physician global assessmentTimepoint: at the end of 3 months of intervention & 6 months;Adverse reactions in both groupsTimepoint: monthly till the end of intervention period at 3 months;Difference in the patient satisfaction score with the treatment in between the groupsTimepoint: at the end of intervention period at 3 months	—

Measure

Time frame

Change in mean MELASQoL in both the groupsTimepoint: at the end of 3 months of intervention & 6 months;Change in mean Melanin Index in both the groupsTimepoint: at the end of 3 months of intervention & 6 months;Photographic improvement in both the groups with physician global assessmentTimepoint: at the end of 3 months of intervention & 6 months;Adverse reactions in both groupsTimepoint: monthly till the end of intervention period at 3 months;Difference in the patient satisfaction score with the treatment in between the groupsTimepoint: at the end of intervention period at 3 months

—

Countries

India

Contacts

Public ContactDr G Manoj Pavan Reddy

All India Institiute of Medical Sciences, New Delhi

aiimsgsr@gmail.com9871744538

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026