Melasma
Conditions
Interventions
Melatonin intervention group: 25 participants (women with facial melasma)
ingestion of one capsule containing 5 mg melatonin once daily in the evening before bed. During the day, facial sunscreen with color should be used (advice to reapply every 3 hours) Sunscreen with Avè
ingestion of one capsule containing capsules with talc (placebo), with orientation for use identical to the active one, once a day, at night, before bedtime. During the day, facial sunscreen with colo
Sponsors
Faculdade de Medicina de Botucatu (FMB Unesp)
Faculdade de Medicina de Botucatu (FMB Unesp)
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Women with facial melasma 18 to 60 years old, Fitzpatrick's phototypes II to V.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Improved quality of life in patients with internationally validated melasma; evaluation at T0 and T8 (60th day of treatment) using the MELASQoL scale; | — |
Countries
Brazil
Contacts
Public ContactHELIO MIOT
Outcome results
None listed