Green Banana Peel Extract for Stasis Dermatitis Treatment

Stasis Dermatitis Clinical Trial

Official title:

Green Banana Peel Extract for Stasis Dermatitis Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06427733
• Other study ID #: Sponsor
• Status: Completed
• Phase: Phase 1
• Start date: February 2, 2024
• Est. completion date: May 15, 2024

Study information

• Verified date: May 2024
• Source: Universidade do Vale do Sapucai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 15, 2024
• Est. primary completion date: March 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Stasis Dermatitis

Intervention

Biological:
• Placebo comparator
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 sunscreen and pharmaceutical formulation containing green banana peel extract

Locations

Country	Name	City	State
Brazil	Vale do Sapucaí University	Pouso Alegre	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of stasis dermatitis	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.	3 months