Topical Metformin Versus Topical Ketotifen in Melasma Treatment

Topical Metfotmin Versus Topical Ketotifen (Alone or in Combination With Microneddling)in Melasma Treatment :Comparative Split Face Study

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.

This research investigates the therapeutic effects of two nanoparticle-based topical treatments-metformin and ketotifen-on melasma. The study employs a split-face design where each patient receives different treatments on each half of their face. Patients are divided into two groups:

Group 1: Undergoes micro-needling sessions for the entire face, followed by the application of topical ketotifen on one half and topical metformin on the other half.

Group 2: Receives only topical applications of ketotifen on one half of the face and metformin on the other half without micro-needling.

The study includes detailed pre-procedure preparation (cleaning and anesthetizing the face) and post-procedure care (application of SPF 50+ sunblock). Clinical assessments include photographic documentation, H-MASI and mH-MASI scoring for melasma severity, patient satisfaction surveys, MELASQOL questionnaires to assess quality-of-life impacts, and monitoring for side effects. Assessments are conducted at baseline, monthly during treatment, and one month after the final session.

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.