Melasma
Conditions
Interventions
This is a randomized, controlled, double-blind, two-arm parallel clinical trial with a therapeutic focus. The study included a total of 30 adult participants diagnosed with facial melasma, randomly al
Sponsors
Unic- Universidade de Cuiabá
Unic- Universidade de Cuiabá
Eligibility
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Adults aged between 18 and 59 years; clinical diagnosis of facial melasma; no use of topical treatments or procedures for melasma in the previous six months; availability for follow-up throughout the study period; and agreement to participate through signed informed consent
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women; use of oral contraceptives or hormone replacement therapy not compatible with the study protocol; use of anabolic agents; concomitant use of systemic antioxidants; use of medications associated with hyperpigmentation; and clinical conditions that, at the investigator’s discretion, could interfere with participant safety or study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to compare the evolution of pigmentation between the pycnogenol treated group and the placebo group as well as to assess the safety of the intervention throughout follow up verified through automated facial image analysis using computational processing and principal component analysis for objective pigmentation measurement and through laboratory tests including complete blood count and liver function tests for safety monitoring with observation of variations in the pigmentation index derived from the first principal component over time and maintenance of laboratory parameters within reference values. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary closing expected | — |
Countries
Brazil
Contacts
Public ContactSullege Suzuki
Unic- Universidade de Cuiabá
Outcome results
None listed