Photoprotection Efficacy With Sunscreen Formulas Containing the Cyclic Merocyanine Long-UVA Absor… (NCT04865094) | Clinical Trial Compass
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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 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;
* 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 …
What they're measuring
1
Biophysical non-invasive assessment of skin color by using Chromameter Post-UVA pigmentation, Erythema
Timeframe: Change from baseline at Day 7
2
Clinical investigator's assessment by using clinical scale