Melasma
Conditions
Keywords
Melasma, banana, skin, sunscreen
Brief summary
To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma.
Detailed description
Objective: to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma. Methods: it will be a clinical, interventional, longitudinal study, random sampling, Sample will have 60 patients divided into two groups. In the Control Group, SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract will be used, and in the Study Group, in addition to SPF 30 sunscreen, pharmaceutical formulation containing green banana peel extract will be used. Patients will undergo treatment for 90 days, evaluated every 30 days through clinical evaluation and MELASQol.
Interventions
BIOLOGICALSPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
BIOLOGICALSPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract
Study Group In addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used.
Sponsors
Universidade do Vale do Sapucai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Female patients with melasma. * Patients aged 18 years or over and 60 years or less. * Patients who agree to participate in the study. -
Exclusion criteria
* Patients who have other types of facial hyperchromia. * Patients who give up, for any reason, to continue treatment. * Patients who have any type of allergic reaction to the product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical analysis of Melasma | 3 months | Analysis of the skin affected by Melasma will be performed with Melasma Area Severity Index (MASI), the most commonly used outcome measure for melasma. |
| Quality of life analysis | 3 months | Analysis of the quality of life of Melasma patients during the study will be performed using the MELASQol Instrument. It is a useful tool in assessing quality of life in patients with melasma. |
Countries
Brazil
Outcome results
None listed