Green Banana Peel Extract for Melasma Treatment

Phase 1

Completed

• Conditions: Melasma
• Interventions: Biological: SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract; Biological: SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract

• Registration Number: NCT05031689
• Lead Sponsor: Universidade do Vale do Sapucai

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.

Study Timeline

• Study Start: 2021-06-30
• Primary Completion: 2021-07-30
• Status Verified: 2021-08
• Study Completion: 2021-08-10
• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-28
• Last Update Submitted: 2021-08-28
• Study First Posted: 2021-09-02
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPF 30 and Placebo	SPF 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
SPF 30 and pharmaceutical formulation with green banana peel	SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract	In Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing the extract of the green banana peel will be used.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Vale do Sapucaí University; 🇧🇷 Pouso Alegre, Minas Gerais, Brazil