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Clinical Trials/NCT06752460
NCT06752460
Not yet recruiting
Not Applicable

Randomized, Open Clinical Study to Evaluate the Protective Potential of EF192B Versus No Treatment

Eurofarma Laboratorios S.A.1 site in 1 country72 target enrollmentAugust 31, 2025

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.

Registry
clinicaltrials.gov
Start Date
August 31, 2025
End Date
October 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Eurofarma Laboratorios S.A.
Responsible Party
Sponsor

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)

Study Sites (1)

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