Topical Metformin Versus Topical Ketotifen in Melasma Treatment

NCT06942390 | Not Yet Recruiting Phase 2

• 1 other identifier: Melasma treatment
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• Reduction in Melasma Severity Index (MASI) Score

  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

  1 month

Study Arms (2)

Micro-Needling Combined with Topical Treatments

EXPERIMENTAL

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.

Device: Micro-Needling Combined with ketofin and metformin

topical Treatments Alone

EXPERIMENTAL

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.

Drug: ketofin and metformin Alone

Interventions

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.

Micro-Needling Combined with Topical 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.

Also known as: topical treatments

topical Treatments Alone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female adults of 18 years and above with bilateral melasma .
• Clinical diagnosis of melasma.
• Mental capacity to give informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Melanosis

Interventions

Metformin; Therapeutics

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Radwa Bakr, Assistant professor

  Assiot university

  STUDY DIRECTOR

Central Study Contacts

Sara Khaled, Resident

CONTACT

01019420120; sarakhaled1098@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at the dermatology department

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 24, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share