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Development of Retinoic Acid Formulation for Acne

Phase 1
Conditions
Acne vulgaris
L60-L75
C17.800.030.150
Disorders of skin appendages
Registration Number
RBR-3t5ts4
Lead Sponsor
Faculdade de Farmácia da Universidade Federal de Minas Gerais
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruitment completed
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

Healthy volunteers; both genders; age between 18 and 35 years

Exclusion Criteria

Present hypersensitivity to any of the components of the formulation; pregnant women; lactating; have skin burns, eczema or any other chronic skin disease; atopic individuals; present any metabolic disease; have any autoimmune disease; having had a vaccine up to two weeks before the start of the study or having the intention to have a vaccine while the study was being conducted; having already undergone chemotherapy treatment or being undergoing this type of treatment; making use of corticosteroid medications; make use of potentially photosensitizing drugs, such as thiazides, tetracyclines, fluoroquinolones, phenothiazines and sulfonamides during the conduct of the experiment; individuals who are exposed to the intense sun frequently or who have been exposed to the intense sun in the last four months; individuals whose forearm skin has undergone procedures such as hair removal, chemical peels, dermabrasion or laser resurfacing.

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Decrease in skin toxicity promoted by topical application of retinoic acid carried in formulations of nanostructured lipid carriers (NLC) and solid lipid nanoparticles (SLN) when compared to the conventional formulation of commercially available retinoic acid (Vitanol®, Stiefel), verified by the reduction of transepidermal water loss, based on a statistically significant finding with a 95% confidence interval.
Secondary Outcome Measures
NameTimeMethod
Secondary outcomes are not expected
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