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Green Banana Peel Extract for Melasma Treatment

Sponsor
Universidade do Vale do Sapucai (Other)
Overall Status
Completed
CT.gov ID
NCT05031689
Collaborator
(none)
74
Enrollment
1
Location
2
Arms
1.3
Actual Duration (Months)
54.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
  • Biological: SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Green Banana Peel Extract for Melasma Treatment
Actual Study Start Date :
Jun 30, 2021
Actual Primary Completion Date :
Jul 30, 2021
Actual Study Completion Date :
Aug 10, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Clinical analysis of Melasma [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vale do Sapucaí University Pouso Alegre Minas Gerais Brazil 37550-000

Sponsors and Collaborators

  • Universidade do Vale do Sapucai

Investigators

  • Principal Investigator: Adriana R dos Anjos Mendonça, PhD, Vale do Sapucaí University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adriana Rodrigues dos Anjos Mendonça, Principal Investigator, Universidade do Vale do Sapucai
ClinicalTrials.gov Identifier:
NCT05031689
Other Study ID Numbers:
  • Melasma
First Posted:
Sep 2, 2021
Last Update Posted:
Sep 2, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Adriana Rodrigues dos Anjos Mendonça, Principal Investigator, Universidade do Vale do Sapucai
Melasma
banana
skin
sunscreen
Additional relevant MeSH terms:
Melanosis
Sunscreening Agents

Study Results

No Results Posted as of Sep 2, 2021