Green Banana Peel Extract for Melasma Treatment

Study Overview
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Brief Summary
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To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma.

Detailed Description
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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.

Official Title
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Green Banana Peel Extract for Melasma Treatment

Conditions
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Melasma

Intervention / Treatment
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* Biological: SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
* Biological: SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: SPF 30 and Placebo<br>Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract | Biological: SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract<br>* Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract<br>|
| Active Comparator: SPF 30 and pharmaceutical formulation with green banana peel<br>In Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing the extract of the green banana peel will be used. | Biological: SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract<br>* Study Group In addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melasma, banana, skin, sunscreen