Photoprotection Efficacy With Sunscreen Formulas Containing the Cyclic Merocyanine Long-UVA Absor… (NCT04865055) | Clinical Trial Compass
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Photoprotection Efficacy With Sunscreen Formulas Containing the Cyclic Merocyanine Long-UVA Absorber MCE, Under Real Sun Exposure
India50 participantsStarted 2021-04-29
Plain-language summary
To evaluate the photo-protector effect of BC\_3 (E212657) formulated in SPF30 compared to SPF30 alone on real sun exposure induced pigmentation in healthy volunteers
Who can participate
Age range18 Years – 45 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:
* The subject is a healthy female volunteer aged between 18-45 years old
* Subjects with skin phototype IV-V and ITA° 4° to 20°.
* Subject who has given freely his or her informed consent and who is cooperative and aware of the necessity and duration of the controls so that perfect adherence to the protocol can be expected
* Subject who is able to read and understand documents transmitted (information sheet and consent form)
* If the subject is a female of childbearing potential and is willing to use a reliable mean of contraception\*(for at least one month before the beginning of the study, and throughout the study) or menopausal women (absence of menstrual periods for one year or more)
* Accepting to stop the usage of all facial skin cosmetics (lotion, cream, powder, make-up) throughout the study duration.
* Subject willing to expose / her face and arms to sun for around 1- 2 hours morning and 1-2 hours afternoon during the day
* sexually active females of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy ortubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant,injection), diaphragm or cervical cap, Intravaginal device, intrauterine device (IUD), condoms.
Exclusion Criteria:
* Female subject who is pregnant (as demonstrated by positive UPT on screening visit) or planning to get pregnant during the study.
* Female subjects who are breast-feeding.
* Subject…
What they're measuring
1
To compare the photo-protective efficacy of two cosmetic investigational products by Clinical scoring done by the study investigator
Timeframe: Change from baseline at Day 7
2
To compare the photo-protective efficacy of two cosmetic investigational products by Non invasive bio-instrumental skin color assessments
Timeframe: Change from baseline at Day 7
3
To compare the photo-protective efficacy of two cosmetic investigational products by Self assessment