Stasis Dermatitis
Conditions
Keywords
Stasis dermatitis, Hyperpigmentation, banana skin, Musa sapientum
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.
Interventions
BIOLOGICALPlacebo 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
BIOLOGICALActive Comparator
SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract
Sponsors
Universidade do Vale do Sapucai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of stasis dermatitis | 3 months | 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. |
Countries
Brazil
Outcome results
None listed