Dermatological Assessment of Photoallergy and Phototoxicity (NCT04250623) | Clinical Trial Compass
CompletedNot Applicable
Dermatological Assessment of Photoallergy and Phototoxicity
Brazil29 participantsStarted 2021-04-12
Plain-language summary
This is a clinical study for health care product safety assessment. The research will be conducted with 40 subjects\*, aged 18 to 70 years. The product will be applied on the right and/or left participant back for 3 consecutive weeks. After 10 days, will have another application of the same product, which will be removed in 24 hours. Medical evaluation will be available throughout the study to assess possible adverse events.
The objective of the study is to observe the effects of the application of the product on the skin and prove the absence of photoallergy and phototoxicity.
\* 29 completed the trial
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Agreement to comply with safety guidelines to minimize the risk of contamination to COVID-19;
* Agreement to perform a molecular test for the detection of COVID-19 to enter the study;
* Healthy participants;
* Non-injured skin in the test region;
* Agreement to adhere to the test procedures and requirements and to attend the institute on the day(s) and at the time(s) determined for the evaluations;
* Ability to consent to participation in the study;
* Age from 18 to 70 years;
* Phototype (Fitzpatrick): II and III;
* Any gender
Exclusion Criteria:
* Participants who belong to the risk group for COVID-19, that is, with diabetes, with chronic cardiovascular, renal and respiratory problems, immunosuppressed or other conditions that the physician deems as belonging to the risk group;
* Skin marks in the experimental area;
* Active dermatoses (local or widespread);
* Pregnant or breastfeeding women;
* History of allergic reactions, irritation or intense feelings of discomfort to topical products;
* History of phototoxic or photoallergic reactions;
* History of allergy to materials used in the study;
* History of atopy;
* Personal or family pathological history of skin cancer;
* History of pathologies aggravated or triggered by ultraviolet radiation;
* Carriers of immunodeficiencies;
* Intense sun exposure or tanning session up to 15 days before the initial evaluation;
* Predicted intense sun exposure or tanning session during the course of the study;
* Pred…