UnknownNot Applicable

Photoprotection Efficacy With Sunscreen Formulas Containing the Cyclic Merocyanine Long-UVA Absorber MCE Under UV Day Light 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 UV Day Light 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;
. 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 and inclusion visit with an authorize delta of ± 2° between screening and inclusion visit (Individual Typologic Angle calculated value);
. female of childbearing potential who are sexually actives using a reliable mean of contraception (for at least three month before the beginning of the study, and throughout the study);
. Female of childbearing potential willing to undergo urine pregnancy test
. informed about the study objectives and procedures, and able to understand them;

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;

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.

What they're measuring

Biophysical non-invasive assessment of skin color by using Chromameter

Timeframe: Change from baseline at Day 7

Clinical investigator's assessment by clinical score

Timeframe: Change from baseline at Day 7

Trial details

NCT IDNCT04866797

SponsorL'Oreal

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-29

Contact for this trial

AUDREY GUENICHE, pHD

+33660992467 agueniche@rd.loreal.com

View on ClinicalTrials.gov More Pigmentation trials