Not Yet RecruitingPhase 2

Topical Metformin Versus Topical Ketotifen in Melasma Treatment

60 participantsStarted 2025-06-01

Plain-language summary

The study aims to evaluate and compare the efficacy and safety of a new formulation of topical metformin (nanoparticles) versus topical ketotifen (nanoparticles), both alone and combined with micro-needling, for the treatment of melasma. It is a double-blinded, randomized, split-face controlled clinical study involving 102 female patients diagnosed with bilateral melasma.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female adults of 18 years and above with bilateral melasma . * Clinical diagnosis of melasma. * Mental capacity to give informed consent. Exclusion Criteria: * Pregnant or nursing women. * Current use of hormonal birth control medication or any hormonal therapy. * Current or previous treatment by depigmenting agents within 3 months * History of laser or MN to the face within 3 months of study enrollment. * Patients with poor wound healing, recurrent herpes simplex and current skin infection (facial warts, molluscum contagiosum) and history of hypertropic scar/keloids. * Photosensitivity. * Patients with unrealistic expectations.

What they're measuring

Reduction in Melasma Severity Index (MASI) Score

Timeframe: 1 month

Trial details

NCT IDNCT06942390

SponsorAssiut University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Sara Khaled, Resident

01019420120 sarakhaled1098@gmail.com

View on ClinicalTrials.gov More Melasma trials