Skin Care, Skin Lesion, Skin Lesions
Conditions
Keywords
Contact test, HRIPT, Lesions
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.
Interventions
DEVICEEF192A
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.
DEVICESaline 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.
Sponsors
Eurofarma Laboratorios S.A.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prove the absence of primary irritability potential of EF192A under maximized conditions | 42 days | * 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. |
Countries
Brazil
Outcome results
None listed