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

Eurofarma

Status: Completed

Conditions: Skin Lesions; Skin Lesion; Skin Care

Treatments: Device: Saline solution; Device: EF192A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06731062

EF192A

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

EF192A

Experimental group

Description:

EF192A will be distributed on a contact test filter paper disc, appropriately identified, in the letter of the alphabet corresponding to the experimental product.

Treatment:

Device: EF192A

Saline Solution

Sham Comparator group

Description:

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.

Treatment:

Device: Saline solution