Topical Metformin Versus Topical Ketotifen in Melasma Treatment

ConditionMelasma

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-60

SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female adults of 18 years and above with bilateral melasma .

Clinical diagnosis of melasma.

Mental capacity to give informed consent.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Micro-Needling Combined with Topical TreatmentsExperimental treatment 1 intervention

Group B: topical Treatments AloneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

1 month

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: