Evaluation of the EF192B Protection Versus No Treatment

Not Applicable

Not yet recruiting

• Conditions: Skin Lesions; Skin Care

• Registration Number: NCT06752460
• Lead Sponsor: Eurofarma Laboratorios S.A.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-30
• Last Update Posted: 2024-12-30
• Study Start: 2025-08-31
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	12 hours

Secondary Outcome Measures

Name	Time	Method
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	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)
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	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
Evaluate EF192B water resistance after four washes	12 hours	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

Trial Locations

Locations (1)

Eurofarma Laboratórios S.A; 🇧🇷 Itapevi, São Paulo, Brazil