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Topical Metformin Versus Topical Ketotifen in Melasma Treatment

A

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)

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

Trial contacts and locations

0

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Central trial contact

Sara Khaled, Resident

Data sourced from clinicaltrials.gov

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