An interventional study of EF192A and Saline solution in Skin Lesion, Skin Lesions and Skin Care, sponsored by Eurofarma Laboratorios S.A.. Completed at 1 site in Brazil. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Eurofarma Laboratorios S.A. · Not applicable, Interventional, and Screening
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.
Eurofarma Laboratorios S.A. is the lead sponsor of 64 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
istory of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.).
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
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
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.
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.
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.
Time frame: 42 days
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Eurofarma Laboratorios S.A.