Chloasma, drug effects
Conditions
Interventions
Cysteamine Intervention Group: 20 participants (women with facial melasma)
application of cysteamine 5% cream over melasma spots (topical administration) for a period of 15 minutes, increasing day by day, up to a maximum of 2 hours (overnight), if there is no irritation. Dur
application of 4% hydroquinone in cream (topical administration) on the stains at night. During the day: application of colored facial sunscreen (guidance for reapplication every 3 hours) Photoage Min
Drug
Sponsors
Faculdade de Medicina de Botucatu (FMB - Unesp)
Escola Paulista de Medicina (EPM/UNIFESP)
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Women with facial melasma 18 to 50 years old, Fitzpatrick's phototypes II to V.
Exclusion criteria
Exclusion criteria: Pregnant and lactating women; women with vitiligo or photosensitizing diseases; individuals who are using other whitening substances and those who refuse to be photographed; photoexposed women and menopausal women (after 50 years).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the severity of melasma assessed using the mMASI score (modified Melasma Area and Severity Index); evaluation at T60 (60th day) and T120 (120th day of treatment); a percentage reduction of at least 20% is expected in T120 compared to T0 ;Evaluation of the severity of melasma assessed using the mMASI score (modified Melasma Area and Severity Index); evaluation at T60 (60th day) and T120 (120th day of treatment); there was a 38% reduction in mMASI in the cysteamine group and a 52% reduction in the control group.;Evaluation of the degree of luminosity of the skin through the colorimetric index; evaluation at T60 (60th day) and T120 (120th day of treatment); expected reduction of at least 20% in T120 compared to T0 in the colorimetric index;Evaluation of the degree of luminosity of the skin through the colorimetric index; evaluation at T60 (60th day) and T120 (120th day of treatment); there was no difference between groups at T120 in relation to T0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improved quality of life in patients with internationally validated melasma; evaluation at T60 (60th day) and T120 (120th day of treatment) using the MELASQoL scale; ;Evaluation of the pigmentation pattern; evaluation at T60 (60th day) and T120 (120th day of treatment);Evaluation of clinical improvement by the participant and the researcher (blind evaluator): classify as neutral improvement, little improvement, great improvement and exceptional improvement; evaluation at T60 (60th day) and T120 (120th day of treatment) | — |
Countries
Brazil
Contacts
Public ContactHélio Miot
Faculdade de Medicina de Botucatu (FMB - Unesp)
Outcome results
None listed