Melasma.Chloasma
Conditions
Interventions
Control group: 50 patients will use a test drug placebo once daily and will apply sunscreen on face 30 minutes before solar exposure whenever it is necessary.
The treatment will last 3 months
Test
Drug
E02.190.755
Sponsors
Medcin Instituto da Pele
Farmoquimica
Eligibility
Sex/Gender
Female
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: 100 participants; age range 25-65 years old; female; fitzpatrick skin types II and III; patients with facial melasma; without any other cutaneous disease; without previous reaction to topical product; the patient should agree with the study-related procedures and the determinated days and time of appointments; Reading; understanding; agreement and signature of patient on the written informed free consent form.
Exclusion criteria
Exclusion criteria: Pregnancy; lactation; hormonal therapy within the last 4 weeks; use of photosensitizing drug; any melasma treatment in the same time;intensive solar exposure within the last 15 days and during the study; cutaneous marks on the experimental area that might interfere with cutaneous reaction evaluation; use of corticoide until 30 days before the selection and during the study;endocrine dysfunction; use of cosmetic products that might cause any facial irritation , even if it is mild such as exfoliating and antiaging products; other conditions that may be considered by doctors as a reason for disqualification of patient’s participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction the intensity and extent of the facial melasma after 12 weeks of treatment, determined by MASI scale (Melasma Severity Index and area). The treatment with the herbal will be considered superior to the placebo, the lower limit of 95% confidence interval is greater than 0.5 for MASI variable. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improves the participant's quality of life will be assessed by applying the MELASQoL. The treatment with the herbal will be considered superior to the placebo, the lower limit of 95% confidence interval is greater than 0.5 to MelasQol variable.; Herbal safety will be assessed by the amount of reported adverse events. | — |
Countries
Brazil
Contacts
Public ContactCamila ;Thales Abreu;Braga
Farmoquimica S.A;Farmoquimica S.A
Outcome results
None listed