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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-20

Study Completion Date

2025-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Skin Lesion Skin Lesions Skin Care

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Induction period (3 weeks): the experimental and control product will be applied through a patch test on the participants' back for 3 consecutive weeks, with 3 weekly applications, with the first week being the primary irritation phase and the two consecutive weeks being the accumulated irritation phase.

Rest period (10 to 15 days): corresponds to the rest period, when participants will remain without any contact test applied to their back, which will follow the induction period, where there will be no application of the experimental and control product. Challenge period (3 days): the experimental and control product will be applied to the participants' back, in a naïve area. Products will be removed after 48 hours, with readings taking place after removal and approximately 24 hours after removal. This period corresponds to the sensitization phase.

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

EF192A

Intervention Type DEVICE

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.

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.

Group Type SHAM_COMPARATOR

Saline solution

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes