Green Banana Peel Extract for Stasis Dermatitis Treatment

Universidade do Vale do Sapucai

Status and phase: Completed; Phase 1

Conditions: Stasis Dermatitis

Treatments: Biological: Placebo comparator; Biological: Active Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT06427733

Sponsor

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Control Group without green banana peel

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo comparator

Study Group with green banana peel

Active Comparator group

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.

Treatment:

Biological: Active Comparator