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
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Melanosis
• Melasma

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