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Interventional study comparing the effectiveness of topical metformin 30 % cream plus hydroquinone 4 % cream vs topical hydroquinone 4% cream alone in melasma -a randomised non inferiority open label study.

Comparison of effectiveness of topical metformin 30% plus 4%hydroquinone cream vs topical hydroquinone 4% cream alone in melasma -A randomised non inferiority open lable study - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076845
Enrollment
60
Registered
2024-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue

Interventions

Intervention1: topical metformin 30% plus 4% hydroquinone cream for a duration of 8 weeks: 1. One group shall be treated with topical metformin 30% plus 4% hydroquinone creamfor 8 weeks Control Interv

Sponsors

SOA university
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: .All clinically diagnosed cases of melasma cases from 18 to 60 years of age 2. Who are not currently on any topical or systemic melasma treatments for one month and who did not receive any cosmetic procedures such as laser ablation, dermabrasion or peels for the last 3 months.

Exclusion criteria

Exclusion criteria: Pregnancy and lactation 2. Active acne vulgaris and Rosacea 3. Females on Oral Contraceptive pills 4. History of allergy to metformin 5. Allergic to propylene glycol 6. H/O liver or Kidney dysfunction

Design outcomes

Primary

MeasureTime frame
on photographic assessment and quantitative assessment using mMASI score.Timepoint: Assessment to be done on every monthly for 4 months—

Secondary

MeasureTime frame
SAFETY PROFILETimepoint: Any patients developing side effects like pruritus, allergic reactions, erythema—

Countries

India

Contacts

Public ContactBikash ranjan Kar

IMS AND SUM HOSPITAL

karbikash@gmail.com08249855790

Outcome results

None listed

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