Topical Metformin Versus Topical Ketotifen in Melasma Treatment

NCT ID: NCT06942390

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-10-30

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.

Conditions

Melasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Micro-Needling Combined with Topical Treatments

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.

Group Type: EXPERIMENTAL

Micro-Needling Combined with ketofin and metformin

Intervention Type: 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.

topical Treatments 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.

Group Type: EXPERIMENTAL

ketofin and metformin Alone

Intervention Type: 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.

Interventions

Micro-Needling Combined with ketofin and metformin

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Other Intervention Names

topical treatments

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sara Khaled AbdElAziz

resident at the dermatology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Radwa Bakr, Assistant professor

Role: STUDY_DIRECTOR

Assiot university

Central Contacts

Sara Khaled, Resident

Role: CONTACT

sarakhaled1098@gmail.com

01019420120

Other Identifiers

Melasma treatment

Identifier Type: -

Identifier Source: org_study_id