Photoprotection Efficacy With Sunscreen Formulas Containing the Cyclic Merocyanine Long-UVA Absor… (NCT04865120) | Clinical Trial Compass
UnknownNot Applicable
Photoprotection Efficacy With Sunscreen Formulas Containing the Cyclic Merocyanine Long-UVA Absorber MCE Under Long-UVA Exposure.
Romania50 participantsStarted 2021-04-29
Plain-language summary
To evaluate the photo-protector effect of BC\_3 (E212657) formulated in SPF compared to SPF alone on long-UVA induced pigmentation in healthy volunteers.
Who can participate
Age range
18 Years – 40 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:
* Healthy female or male volunteer;
* from 18 to 40 years old;
* uniform skin color all over on the investigational zones;
* skin type III or IV according to the Fitzpatrick classification;
* ITA° between 10° and 35° at screening visit with an authorize delta of ± 2° at inclusion visit (D1) (Individual Typologic Angle calculated value);
* female of childbearing age using a reliable mean of contraception (for at least three month before the beginning of the study, and throughout the study);
* informed about the study objectives and procedures, and able to understand them;
* willing and able to fulfill the study requirements and schedule.
* All subjects will have to give their written informed consent.
Exclusion Criteria:
* Female in pregnancy (positive pregnancy-test performed before inclusion) or lactation or without effective contraception ;
* having planned U.V. exposure of the investigational zones (sunlight or sunbeds) throughout the study;
* having used sunbed or sun exposure of the investigational zones within the 3 months before inclusion;
* having sunburn (erythema) on the back;
* dermatological disorders affecting the investigational zones (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems);
* history of skin cancer;
* history of abnormal response to sun;
* presence of recent suntan (according to Investigator opinion) or photo-test marks;
* history of allergy, hypersensitivity, or any serious…
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.