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Completed

NCT Number: NCT05031689

Green Banana Peel Extract for Melasma Treatment

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

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Vale do Sapucaí University

Pouso Alegre, Minas Gerais, 37550-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract

Biological

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

Biological

Study Group In addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Universidade do Vale do Sapucai

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 2, 2021
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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