Green Banana Peel Extract for Stasis Dermatitis Treatment

NCT ID: NCT06427733

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-02

Study Completion Date

2024-05-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Stasis Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control Group without green banana peel

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

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type 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

Study Group with green banana peel

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.

Group Type ACTIVE_COMPARATOR

Active Comparator

Intervention Type BIOLOGICAL

SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract

Interventions

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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

Intervention Type BIOLOGICAL

Active Comparator

SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade do Vale do Sapucai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adriana R dos Anjos Mendonça, PhD

Role: PRINCIPAL_INVESTIGATOR

Vale do Sapucaí University

Locations

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Vale do Sapucaí University

Pouso Alegre, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Sponsor

Identifier Type: -

Identifier Source: org_study_id

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