Skin disorders
Conditions
Interventions
All participants, irrespective of which group are randomized, will receive facial sunscreen with reapplication orientation every 3 hours and triple topical combination for nocturnal application on the
another will receive the combination of oral tranexamic acid 250mg and Pycnogenol® every 12 hours (in the same tablet) and a last group will receive placebo, every 12 hours, with blinding for particip
Drug
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 between the ages of 18 and 60 with facial melasma; without treatment for at least 60 days; except for the use of sunscreen.
Exclusion criteria
Exclusion criteria: Patients with concomitant facial dermatoses; photosensitivity dermatoses; collagenosis; blood dyscrasias and / or under the use of anticoagulant medication; history of thrombosis; immunosuppressed patients will be excluded; pregnant; lactating women. Phenotypic extremes will be excluded: red and black because melasma is rarely mentioned in these groups. Obese; smokers; personal history of abortion; sedentary; with personal or family history of previous thrombotic event (pulmonary thromboembolism or deep vein thrombosis) are at greater risk of thromboembolism and, therefore, contraindication to the use of oral tranexamic acid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of facial melasma pigmentation, verified by variation of the mMASI ocorre of at least 20%, in the before and after interventor measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of melasma pigmentation, verified by colorimetric index variation and MELASQoL by at least 20% in the before and after interventor measurements. | — |
Countries
Brazil
Contacts
Public ContactHélio Miot
Faculdade de Medicina de Botucatu (FMB - Unesp)
Outcome results
None listed