NCT06731062

Assessment of EF192A Potential Sensitization and Accumulated and Primary Irritability in Controlled/Maximized Conditions

Assessment of the Primary, Accumulated Irritability and Sensitization Potential of EF192A Under Controlled and Maximized Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The investigational product constitutes a medical device that is freely accessible to consumers and, as such, must be safe under real or reasonably foreseeable conditions of use and its safety must be tested before being placed on the market. Therefore, this study was designed to evaluate the biocompatibility of the experimental product, as provided for in legislation.

Conditions

• Skin Lesion
• Skin Lesions
• Skin Care

Interventions

Type	Name	Description
DEVICE	EF192A	EF192A will be applied through a patch test to the participants' backs for 3 consecutive weeks, with 3 weekly applications. Afterwards, there will be a rest period of between 10 and 15 days. EF192A will be reapplied to the participants' back in a naive area and removed after 48 hours.
DEVICE	Saline solution	The saline solution will be applied via patch test to the participants' backs for 3 consecutive weeks, with 3 weekly applications. Afterwards, there will be a rest period of between 10 and 15 days. The saline solution will be applied again to the participants' back in a naive area and removed after 48 hours.

Timeline

• Start date: 2025-01-20
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2024-12-12
• Last updated: 2025-06-15

Locations

1 site across 1 country: Brazil