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Green Banana Peel Extract for Melasma Treatment

Primary Purpose

Melasma

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract
Sponsored by
Universidade do Vale do Sapucai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma focused on measuring Melasma, banana, skin, sunscreen

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Vale do Sapucaí University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

SPF 30 and Placebo

SPF 30 and pharmaceutical formulation with green banana peel

Arm Description

Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 20, 2021
Last Updated
August 28, 2021
Sponsor
Universidade do Vale do Sapucai
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1. Study Identification

Unique Protocol Identification Number
NCT05031689
Brief Title
Green Banana Peel Extract for Melasma Treatment
Official Title
Green Banana Peel Extract for Melasma Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Vale do Sapucai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
Keywords
Melasma, banana, skin, sunscreen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPF 30 and Placebo
Arm Type
Placebo Comparator
Arm Description
Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
Arm Title
SPF 30 and pharmaceutical formulation with green banana peel
Arm Type
Active Comparator
Arm Description
In Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing the extract of the green banana peel will be used.
Intervention Type
Biological
Intervention Name(s)
SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
Intervention Description
Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
Intervention Type
Biological
Intervention Name(s)
SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract
Intervention Description
Study Group In addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used.
Primary Outcome Measure Information:
Title
Clinical analysis of Melasma
Description
Analysis of the skin affected by Melasma will be performed with Melasma Area Severity Index (MASI), the most commonly used outcome measure for melasma.
Time Frame
3 months
Title
Quality of life analysis
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana R dos Anjos Mendonça, PhD
Organizational Affiliation
Vale do Sapucaí University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vale do Sapucaí University
City
Pouso Alegre
State/Province
Minas Gerais
ZIP/Postal Code
37550-000
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Green Banana Peel Extract for Melasma Treatment

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