Melasma
Conditions
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.
Interventions
DEVICEMicro-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.
DRUGketofin 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.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Melasma Severity Index (MASI) Score | 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 |
Contacts
Primary ContactSara Khaled, Resident
Outcome results
None listed