Green Banana Peel Extract for Stasis Dermatitis Treatment

NCT06427733 | Completed Phase 1 DMC

• 1 other identifier: Sponsor
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stasis Dermatitis

Keywords

Stasis dermatitis; Hyperpigmentation; banana skin; Musa sapientum

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Biological: Placebo comparator

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.

Biological: Active Comparator

Interventions

Placebo comparator 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

Control Group without green banana peel

Active Comparator BIOLOGICAL

SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract

Study Group with green banana peel

Eligibility Criteria

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

You may qualify if:

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

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

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

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: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 24, 2024
• Study Start: February 2, 2024
• Primary Completion: March 2, 2024
• Study Completion: May 15, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

BR (1)