Status:
UNKNOWN
Photoprotection Efficacy With Sunscreen Formulas Containing the Cyclic Merocyanine Long-UVA Absorber MCE Under Long-UVA Exposure
Lead Sponsor:
L'Oreal
Conditions:
Pigmentation
Redness
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief 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.
Detailed Description
The sun emits numerous radiations, of which 10% are constituted by ultraviolet light. Only ultraviolet B (UVB, 280-320 nm) and ultraviolet A (UVA, 320-400 nm) reach the surface of the earth. Poor pene...
Eligibility Criteria
Inclusion
- 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
- 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 reaction to any cosmetic product;
- any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator;
- having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g. steroidal and non-steroidal anti-inflammatory drugs, insulin, antihistamines, antihypertensive, antibiotics -e.g. quinolone, tetracycline, thiazides, fluoroquinolones-), or any medication known to cause abnormal responses to U.V. exposure (e.g. vitamin A derivatives, psoralen, aminolevulinic acid derivatives, etc.), or having planned to use these medications during the study;
- having used within the 3 months before inclusion any depigmenting / whitening or propigmenting topical treatments, or any systemic treatment that would interfere with the study assessments (anti-inflammatory drugs, corticoids, retinoids, hydroquinone, etc.);
- unable to be contacted by phone in case of emergency;
- having participated within the 30 days before inclusion or currently participating in another clinical study.
- Deprived of liberty by adjunction or by official decision.
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 29 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04865094
Start Date
April 29 2021
End Date
April 29 2021
Last Update
April 29 2021
Active Locations (1)
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1
CIDP Biotechnology
Bucharest, Romania, 011607