## Protocol Section
### Identification Module
**NCT ID:** NCT06427733

**Brief Title:** Green Banana Peel Extract for Stasis Dermatitis Treatment

**Official Title:** Green Banana Peel Extract for Stasis Dermatitis Treatment

#### Organization Study ID Info
**ID:** Sponsor
#### Organization
**Class:** OTHER
**Full Name:** Universidade do Vale do Sapucai
### Status Module
#### Completion Date
**Date:** 2024-05-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-03-02

**Type:** ACTUAL

#### Start Date
**Date:** 2024-02-02

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universidade do Vale do Sapucai

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Stasis Dermatitis

**Keywords:**

- Stasis dermatitis

- Hyperpigmentation

- banana skin

- Musa sapientum

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Biological: Placebo comparator

**Label:** Control Group without green banana peel

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Biological: Active Comparator

**Label:** Study Group with green banana peel

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control Group without green banana peel

**Description:** 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

**Name:** Placebo comparator

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Study Group with green banana peel

**Description:** SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract

**Name:** Active Comparator

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Occurence of stasis dermatitis

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Pouso Alegre

**Country:** Brazil

**Facility:** Vale do Sapucaí University

**State:** Minas Gerais

**Zip:** 37550-000

#### Overall Officials

**Official 1:**

**Affiliation:** Vale do Sapucaí University

**Name:** Adriana R dos Anjos Mendonça, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7067

- Name: Dermatitis

- Relevance: HIGH

- As Found: Dermatitis

- ID: M19760

- Name: Hyperpigmentation

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003872

- Term: Dermatitis

### Intervention Browse Module - Browse Branches

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M16255

- Name: Sunscreening Agents

- Relevance: LOW

- As Found: Unknown

- ID: T255

- Name: Plantain

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
