This study was designed with the objective of evaluating the protection potential provided by the experimental product EF192B by evaluating its barrier formation capacity. Once its ability to form a barrier is confirmed, EF192B ability to protect against small skin injuries, such as small cuts, bruises, blisters and cracks is confirmed. The barrier formation also guarantees protection against the formation of calluses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
EF192B will be applied after the tape strriping procedure and will be reapplied after 12 hours.
Eurofarma Laboratórios S.A
Itapevi, São Paulo, Brazil
Evaluate the effect of EF192B on the curative effect in the protection of small skin lesions through the formation of a barrier, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.
Time frame: 12 hours
Efficacy of the EF192B in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.
Time frame: 12 hours
Evaluate the efficacy of EF192B barrier formation through the range of transepidermal water loss 3 minutes, 6 hours, and 24 hours after its administration
Evaluation of barrier formation through transepidermal water loss range 3 (±1) minutes, 6 hours (± 10 minutes), and 24 hours (± 30 minutes) after the end of tape stripping versus the measurement obtained immediately after tape stripping (TEWL0)
Time frame: 24 hours
Evaluate the efficacy of EF192B barrier formation through the range of corneometry 3 minutes, 6 hours, 12 hours, and 24 hours after its administration
Evaluation of barrier formation through corneometry range 3 (± 1) minutes, 6 hours (± 10 minutes), 12 hours (± 20 minutes), and 24 hours (± 30 minutes) after the end of tape stripping versus the measurement obtained immediately after tape stripping
Time frame: 24 hours
Evaluate EF192B water resistance after four washes
Water resistance as assessed by the average range of color change to activated charcoal pigment one (01), two (02), three (03), and four (04) washes after administration of the investigational product
Time frame: 12 hours
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