Topical Metformin Versus Topical Ketotifen in Melasma Treatment

Assiut University

Status and phase: Begins enrollment this month; Phase 2

Conditions: Melasma

Treatments: Device: Micro-Needling Combined with ketofin and metformin; Drug: ketofin and metformin Alone

Study type: Interventional

Funder types: Other

Identifiers

NCT06942390

Melasma treatment

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Micro-Needling Combined with Topical Treatments

Experimental group

Description:

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.

Treatment:

Device: Micro-Needling Combined with ketofin and metformin

topical Treatments Alone

Experimental group

Description:

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.

Treatment:

Drug: ketofin and metformin Alone