Facial melasma (chloasma) Skin disorders Women
Conditions
Interventions
The participants will be allocated, randomly and blindly, into four different treatment groups. Control group (CG): 16 women with facial melasma who will receive the current standard treatment, which
Drug
Procedure/surgery
Sponsors
Escola Paulista de Medicina (EPM/UNIFESP)
Escola Paulista de Medicina (EPM/UNIFESP)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: women with mild to severe facial melasma with moderately to severe mMASI clinically proven by a dermatologist titled during the medical visit and who have been untreated for melasma for at least 30 days, except for the use of sunscreen
Exclusion criteria
Exclusion criteria: other concomitant facial dermatoses, photosensitivity dermatoses, collagenoses, blood dyscrasias or under the use of anticoagulant medication, immunosuppressed; pregnant and lactating women;phenotypic extremes red and black, because melasma is rarely mentioned in these groups. Obese, users of oral contraceptives, sedentary or with a personal or family history of previous thrombotic event have a higher risk of thromboembolism, so will be deallocated from the block with oral tranexamic acid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: reduction of facial melasma pigmentation, verified by variation of the mMASI score of at least 20%, in the before and after intervention measurements (T0 and T60;Expected outcome 2: reduction of facial melasma pigmentation, verified by colorimetric index variation of at least 20% in the before and after intervention measurements (T0 and T60) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome 1: higher quality of life, verified by the variation of MELASQol by at least 20% in the measurements before and after intervention (T0 and T60);Secondary outcome 2: reduction of melanin pigmentation of melasma, verified by the variation of the dermatoscopy pigmentation in at least 20% in the measurements before and after intervention (T0 and T60);Secondary outcome 3: clinical improvement, verified through questionnaire answered by the participant themselves exibiting variation of at least 20% before and after intervention (T0, T60 and T120). The questionnaire was criated and consists of a question about how the participant would rate the state of the skin on his face from 1 to 10, with 1 and 2 meaning "terrible", 3 and 4 meaning "bad", 5 and 6 meaning "regular", 7 and 8 mean "good" and 9 and 10 mean "excellent." ;Secondary outcome 4: histological improvement, verified by variation of pigmentation in the basal layer, dermal solar elastosis and alterations in the collagen of at least 20% before and after intervention (T0 and T60) | — |
Countries
Brazil
Contacts
Public ContactEdileia;Hélio Bagatin;Miot
Escola Paulista de Medicina (EPM/UNIFESP);Faculdade de Medicina de Botucatu (FMB - Unesp)
Outcome results
None listed