Metformin cream in Melasma treatment: a comparison with other options

Clinical study on the efficacy, safety, and mechanism of action of 30% topical Metformin, compared to 4% Hydroquinone and the combination of 30% Metformin with 10% Niacinamide in the treatment of facial Melasma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-102t5vqc

Enrollment

Unknown

Registered

2025-11-11

Start date

2025-03-14

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Melasma

Interventions

A randomized, double-blind, parallel, prospective clinical trial of therapeutic intervention. The selected participants will be randomized into blocks using computer simulation and allocated consecuti

Eligibility

Sex/Gender

Female

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Women; age between 18 and 60 years old; with moderate to severe facial melasma or mMasi greater than 5; without treatment for at least 45 days except of the using of sunscreen

Exclusion criteria

Exclusion criteria: Pregnant and lactating women; carriers of other concomitant facial dermatoses; dermatoses with photosensitivity; melasma with mMASI less than 5; history of hypersensitivity or local adverse reactions to the use of hydroquinone, meftomin or niacinamide or any other component of the formulation described

Design outcomes

Primary

Measure	Time frame
Evaluate the safety and efficacy of 30% topical metformin compared to 4% hydroquinone in the treatment of facial melasma in women. ;Evaluate the histological changes of the epidermis and upper dermis after the treatment of facial melasma with 30% topical metformin compared to 4% topical hydroquinone. ;Evaluate whether the combination of 30% metformin with 10% niacinamide has superior lightening potential compared to 30% metformin alone in the treatment of facial melasma.	—

Measure

Time frame

Evaluate the safety and efficacy of 30% topical metformin compared to 4% hydroquinone in the treatment of facial melasma in women. ;Evaluate the histological changes of the epidermis and upper dermis after the treatment of facial melasma with 30% topical metformin compared to 4% topical hydroquinone. ;Evaluate whether the combination of 30% metformin with 10% niacinamide has superior lightening potential compared to 30% metformin alone in the treatment of facial melasma.

—

Secondary

Measure	Time frame
No secondary outcomes are expected.	—

Countries

Brazil

Contacts

Public ContactHélio Miot

Universidade Estadual Paulista (UNESP)

heliomiot@gmail.com+55(14)38134727

Outcome results

None listed

Source: REBEC (via WHO ICTRP)