Clinical trial NCT06731062: Assessment of EF192A Potential Sensitization and Accumulated and Primary Irritability in Controlled/Maximized Conditions
Official title: Assessment of the Primary, Accumulated Irritability and Sensitization Potential of EF192A Under Controlled and Maximized Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Lesion
Skin Lesions
Skin Care
Keywords: Contact test
HRIPT
Lesions
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2024-12-12
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SCREENING

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Prove the absence of primary irritability potential of EF192A under maximized conditions
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Itapevi
country: Brazil
facility: Eurofarma Laboratórios S.A
state: São Paulo
Study officials:
References: