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 range18 Years – 40 Years

SexALL

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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;
✕. 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;

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