Randomized, Open Clinical Study to Evaluate the Protective Potential of EF192B Versus No Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Skin Lesions
- Sponsor
- Eurofarma Laboratorios S.A.
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Efficacy of the EF192B in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.(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(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(24 hours)
- Evaluate EF192B water resistance after four washes(12 hours)