Assessment of EF192A Potential Sensitization and Accumulated and Primary Irritability in Controlled/Maximized Conditions (Spray A)

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Lesion; Skin Care; Skin Lesions
• Intervention / Treatment: Device: Saline solution; Device: EF192A

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Itapevi, São Paulo, Brazil, 06696-000
      • Eurofarma Laboratórios S.A

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age between 18 and 70 years old.
• Fitzpatrick phototype I to IV.
• Presence of intact skin in the test region.
• Agreement to comply with the study procedures and requirements and attend the institute on the days and times determined for the assessments.
• Signature of the Informed Consent Form (ICF) before carrying out any study procedure.

Exclusion Criteria:

• Presence of skin marks in the test region that interfere with the assessment of possible skin reactions (for example, pigmentation disorders, vascular malformations, scars, increased hairiness, large quantities of ephelides and nevus, sunburn).
• Presence of active dermatosis (local or disseminated) that could interfere with the study results.

istory of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.).

- History of allergic reactions, irritation or intense sensations of discomfort to topical products such as, for example, cosmetics, health products or medicines.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Saline Solution; Saline solution - The sterile saline solution (NaCl 0.9%) will be used as control in another contact test filter paper disc, appropriately identified, in the letter of the alphabet corresponding to the control.	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.
Experimental: EF192A; EF192A will be distributed on a contact test filter paper disc, appropriately identified, in the letter of the alphabet corresponding to the experimental product.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prove the absence of primary irritability potential of EF192A under maximized conditions	Occurrence of primary irritation;; Occurrence of accumulated irritation;; Occurrence of sensitization;; Occurrence of AEs ;; Treatment discontinuations due to AEs. It is expected that after the study period, the product will be considered safe because it does not promote a positive irritability response and skin sensitization in the study group. No statistical inference analysis will be performed. The results will be presented in the form of tables demonstrating whether there was a positive response of irritability or skin sensitization in the study group or not. During the study, the regions of the product and control application will be evaluated and if any clinical sign is found, it will be classified according to the scale recommended by the International Contact Dermatitis Research Group - ICDRG.	42 days

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Lesions; HRIPT; Contact test
• Other Study ID Numbers: EF192A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No