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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.