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To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPF 30 and Placebo | Placebo Comparator | Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract |
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| SPF 30 and pharmaceutical formulation with green banana peel | Active Comparator | In Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing the extract of the green banana peel will be used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract | Biological | Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical analysis of Melasma | Analysis of the skin affected by Melasma will be performed with Melasma Area Severity Index (MASI), the most commonly used outcome measure for melasma. | 3 months |
| Quality of life analysis | 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. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adriana R dos Anjos Mendonça, PhD | Vale do Sapucaà University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vale do Sapucaà University | Pouso Alegre | Minas Gerais | 37550-000 | Brazil |
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004339 | Drug Compounding |
| ID | Term |
|---|---|
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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| SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract | Biological | Study Group In addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used. |
|