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NCT Number: NCT06942390

Topical Metformin Versus Topical Ketotifen in Melasma Treatment

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Micro-Needling Combined with ketofin and metformin

Device

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.

ketofin and metformin Alone

Drug

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.

Other names: topical treatments

Primary outcomes

  1. Reduction in Melasma Severity Index (MASI) Score

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Khaled, Resident

CONTACT

[email protected]

01019420120

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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