A study for the treatment of melasma which compares the effectiveness and side effects of metformin cream with triple combination cream which contains steroid plus hydroquinone plus retinoid skin lightening agents and tranexamic acid cream.

A randomised comparative study to evaluate the efficacy and safety of thirty percent metformin cream versus triple combination cream versus tranexamic acid cream in the treatment of melasma - Nil

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070009

Enrollment

120

Registered

2024-07-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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: 10% Topical tranexamic acid cream: Group C will receive sunscreen with spf 30 in the morning and topical 10% tranexamic acid cream at night for 12 weeks. Intervention2: 30% metformin cr

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients willing to give informed consent. 2. Both male and female patients aged more than 18yrs 3. Patients with clinically diagnosed melasma. 4. Patients with melasma who have not applied any topical creams since two weeks/ who have not taken oral steroids since the last one month/ done any procedures like lasers/ chemical peels.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women 2. Patients on oral contraceptives, phenytoin 3. Patients on renal dysfunction 4. Patients allergic to the medications under trial 5. Patients with acne vulgaris/ rosacea 6.Patients with facial hair (beard)

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of 30% metformin cream versus triple combination cream and 10 % tranexamic acid cream in the reduction of MASI (Melasma Area and Severity Index) score and its safety in the treatment of melasma.Timepoint: At 4 weeks, 8 weeks, 12 weeks follow up	—

Secondary

Measure	Time frame
MASI score will be assessed at 4 weeks, 8 weeks and 12 weeks follow up along with simultaneous serial digital photographsTimepoint: At 4 weeks, 8 weeks, 12 weeks follow up	—

Countries

India

Contacts

Public ContactNamitha P

Shri Atal Bihari Vajpayee Medical College and Research Institute

dhruvanamitha@gmail.com9632085655

Outcome results

None listed

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