Green Banana Peel Extract for Melasma Treatment

August 28, 2021 updated by: Adriana Rodrigues dos Anjos Mendonça, Universidade do Vale do Sapucai
To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of melasma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Pouso Alegre, Minas Gerais, Brazil, 37550-000
        • Vale do Sapucaí University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: SPF 30 and Placebo
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
Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
ACTIVE_COMPARATOR: SPF 30 and pharmaceutical formulation with green banana peel
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
Study Group In addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical analysis of Melasma
Time Frame: 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.
3 months
Quality of life analysis
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Vale do Sapucai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2021

Primary Completion (ACTUAL)

July 30, 2021

Study Completion (ACTUAL)

August 10, 2021

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

August 28, 2021

First Posted (ACTUAL)

September 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 28, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • melasma

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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