Green Banana Peel Extract for Stasis Dermatitis Treatment

Phase 1

Completed

• Conditions: Stasis Dermatitis
• Interventions: Biological: Placebo comparator; Biological: Active Comparator

• Registration Number: NCT06427733
• Lead Sponsor: Universidade do Vale do Sapucai

Brief Summary

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

Detailed Description

Objective: to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of stasis dermatitis. Methods: it will be a clinical, interventional, longitudinal study, random sampling, Sample will have 20 patients divided into two groups. In the Control Group, a moisturizing cream with SPF 30 sunscreen plus a pharmaceutical formulation without green banana peel extract will be used, and in the Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used. Patients will undergo treatment for 90 days, applying the formulation twice a day, evaluated every 45 days through clinical, photographic and Chromatic Palette evaluation.

Study Timeline

• Study Start: 2024-02-02
• Primary Completion: 2024-03-02
• Status Verified: 2024-05
• Study Completion: 2024-05-15
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-24
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with stasis dermatitis.
• 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 hyperchromia in the legs.
• Patients known to have an allergic reaction to bananas.
• Patients who give up, for any reason, to continue treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group without green banana peel	Placebo comparator	SPF 30 and Placebo Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
Study Group with green banana peel	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.

Primary Outcome Measures

Name	Time	Method
Occurence of stasis dermatitis	3 months	Macroscopic Analysis: The occurrence of stasis dermatitis will be determined by hyperpigmentation, measured using the Chromatic Palette. Changes in skin color vary from ecchymosis, hematomas, erythema, hyperpigmentation, hypochromia and cyanosis. The focus of our study being hyperpigmentation, the shades vary between brownish, grayish and reddish, depending on the evolution, clinical duration and skin color and severity of stasis dermatitis. The positioning of colors on a gradient scale in columns and lines favors the comparative process and location between nearby shades corresponding to the observed evidence. The inclusion of codes makes it possible to locate and classify skin colors in the situations in which they will be evaluated. In the final version that will be used, there are 72 color possibilities.

Trial Locations

Locations (1)

Vale do Sapucaí University; 🇧🇷 Pouso Alegre, Minas Gerais, Brazil