Green Banana Peel Extract for Melasma Treatment

NCT05031689 | Completed Phase 1 DMC

• 1 other identifier: Melasma
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Melasma

Keywords

Melasma; banana; skin; sunscreen

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

SPF 30 and Placebo

PLACEBO COMPARATOR

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

SPF 30 and pharmaceutical formulation with green banana peel

ACTIVE COMPARATOR

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

Interventions

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 and Placebo

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.

SPF 30 and pharmaceutical formulation with green banana peel

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients with melasma.
• Patients aged 18 years or over and 60 years or less.
• Patients who agree to participate in the study. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Vale do Sapucaí University

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Location

MeSH Terms

Conditions

Melanosis

Interventions

Drug Compounding

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Adriana R dos Anjos Mendonça, PhD

  Vale do Sapucaí University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 2, 2021
• Study Start: June 30, 2021
• Primary Completion: July 30, 2021
• Study Completion: August 10, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-08

Locations

BR (1)