A Phase 1 interventional study of Placebo comparator and Active Comparator in Stasis Dermatitis, sponsored by Universidade do Vale do Sapucai. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by Universidade do Vale do Sapucai · Phase 1, Interventional, and Treatment
To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of stasis dermatitis.
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.
106 studies on the registry are indexed under Hyperpigmentation; 20 are open to participants now.
This study's enrollment of 20 is below the median of 35 across 93 interventional studies indexed under Hyperpigmentation.
Browse Hyperpigmentation studies →Universidade do Vale do Sapucai is the lead sponsor of 28 studies on the registry; none are open to participants now.
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Exclusion Criteria:
SPF 30 and Placebo Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
Biological: Placebo 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
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
SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract
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.
Time frame: 3 months
Ran from Feb 2024 to primary completion in Mar 2024, 1 month.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Universidade do Vale do Sapucai