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NCT05031689 Clinical Trial

Green Banana Peel Extract for Melasma Treatment

Melasma Clinical Trial

Official title:
Green Banana Peel Extract for Melasma Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05031689
Other study ID # Melasma
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 30, 2021
Est. completion date August 10, 2021

Study information
Verified date August 2021
Source Universidade do Vale do Sapucai
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date August 10, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• 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 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.

Locations
Country Name City State
Brazil Vale do Sapucaí University Pouso Alegre Minas Gerais

Sponsors (1)
Lead Sponsor Collaborator
Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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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