Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Photosensitization of a Scar Gel
Brazil55 participantsStarted 2025-01-13
Plain-language summary
Evaluate the potential of Primary Dermal Irritability, Accumulated Dermal Irritability, Dermal Sensitization, Photoallergy and Photosensitization, of health products through the application of Patch Test, proving the safety of the product for topical use. The study will be conducted with a Brazilian sample in which 55 research participants will be included. Depending on the results, the present study may support the claim: dermatologically tested, non-irritating, non-sensitizing, non-photoirritating and non-photosensitizing.
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:
* Participants of both sexes aged 18 to 70 years;
* Phototypes: I, II, III, and IV (For the phototest trial, only phototypes II and III will be considered);
* Intact skin in the application area;
* Willingness to follow the trial procedures and attend the center on the specified dates and times for medical evaluations and for application and reading of dressings;
* Understanding, consent, and signing of the Informed Consent Form (ICF).
Exclusion Criteria:
* Pregnancy or risk of pregnancy/lactation;
* Use of anti-inflammatory drugs within 30 days and/or immunosuppressive drugs up to three months before selection;
* Immunosuppression due to drugs or active diseases;
* Uncompensated endocrinopathies;
* Personal history of atopy;
* Intense sun exposure or tanning sessions up to 15 days before the evaluation or during the study period;
* Plans to bathe in the sea, pool, or sauna during the study;
* Practice of water sports during the study;
* Dermographism;
* Use of oral or topical treatments with vitamin A acid and/or its derivatives up to one month before the start of the study;
* Aesthetic and/or dermatological treatments on the body within three weeks prior to selection;
* Scheduled vaccination during the study period or within three weeks prior to selection;
* History of sensitization, irritation, or photosensitization to topical products;
* Active skin conditions (local and/or widespread) that could interfere with study results;
* Skin reactivity;
* Us…
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.