Efficacy of the oral use of the drug melatonin in the treatment of facial melasma in women.
Not Applicable
- Conditions
- Melasma
- Registration Number
- RBR-10gx2qhj
- Lead Sponsor
- Faculdade de Medicina de Botucatu (FMB Unesp)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Women with facial melasma 18 to 60 years old, Fitzpatrick's phototypes II to V.
Exclusion Criteria
Patients with other concomitant facial skin diseases, skin diseases with photosensitivity, melasma with mMASI less than 5, history of hypersensitivity to the active substance oral melatonin or to any other component of the formulation described, pregnant or lactating women.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of the severity of melasma assessed through the mMASI Score (modified Melasma Area and Severity Index); evaluation at T0 and T8 (60th day of treatment); a percentage reduction of at least 20% is expected in T8 compared to T0
- Secondary Outcome Measures
Name Time Method Improved quality of life in patients with internationally validated melasma; evaluation at T0 and T8 (60th day of treatment) using the MELASQoL scale;