Micro-Needling Combined with ketofin and metformin
DeviceAfter 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.
NCT Number: NCT06942390
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.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Interventional
Phase 2
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Other names: topical treatments
Time frame: 1 month
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
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Topical Metfotmin Versus Topical Ketotifen (Alone or in Combination With Microneddling)in Melasma Treatment :Comparative Split Face Study
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