Topical Metformin Versus Topical Ketotifen in Melasma Treatment

Phase 2

Not yet recruiting

• Conditions: Melasma
• Interventions: Device: Micro-Needling Combined with ketofin and metformin; Drug: ketofin and metformin Alone

• Registration Number: NCT06942390
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Study First Posted: 2025-04-24
• Last Update Posted: 2025-04-24
• Study Start: 2025-06-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micro-Needling Combined with Topical Treatments	Micro-Needling Combined with ketofin and metformin	This arm involves 51 patients receiving four sessions of micro-needling across their entire face at four-week intervals. After micro-needling, topical ketotifen is applied to one half of the face and topical metformin to the other half. Between sessions, patients continue daily application of both treatments.
topical Treatments Alone	ketofin and metformin Alone	This arm includes 51 patients receiving daily applications of topical ketotifen on one half of their face and topical metformin on the other half without undergoing micro-needling sessions.

Primary Outcome Measures

Name	Time	Method
Reduction in Melasma Severity Index (MASI) Score	1 month	Measurement of changes in MASI score from baseline to the end of treatment (1 month). MASI is a validated tool used to assess the severity and area of melasma pigmentation, with lower scores indicating improvement.The Melasma Area and Severity Index (MASI) quantifies melasma severity using a 0-48 scale, where 0 = no melasma and 48 = maximum severity