Photoprotection Efficiency with Sunscreen Formulas Under Visible Light Exposure. (NCT06827392) | Clinical Trial Compass
CompletedNot Applicable
Photoprotection Efficiency with Sunscreen Formulas Under Visible Light Exposure.
France20 participantsStarted 2016-09-06
Plain-language summary
To evaluate the protective effect of three Laboratoire VICHY formulations on the pigmentation caused by visible light in comparison to a non-treated control zone in healthy volunteers
Who can participate
Age range18 Years – 50 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 subject of both sexes, aged from 18 to 50 years, of phototype IIIb, IV or V on the Fitzpatrick scale (1988),
* Subject in good health having a normal results at the physical examination and having medical antecedents compatible with the study requirements,
* Woman of childbearing potential using a reliable means of contraception (contraceptive pill, contraceptive implant, IUD, bilateral tubal ligature/section, condoms) and agreeing to not change her method of contraception from one month before the start of the study and for the entire duration of the study,
* Healthy woman of non-childbearing potential, that is post-menopausal (absence of menstrual bleeding for one year prior to screening, hysterectomy or bilateral ovariectomy),
* Subject having signed and dated the informed consent form before any action connected to the study was performed,
* Subject willing and able to follow all the study procedures and complete the whole study,
* Subject affiliated to a social security system (according to French legislation: Law 2004-806 and its implementing decree n°2006-477 of 26 April 2006).
Exclusion Criteria:
* Woman who was pregnant or lactating or who planned to become pregnant during the study period,
* Subject having an underlying pathology, or a surgical, physical or medical status which, according to the investigator, could interfere with the interpretation of the study results, such as:
* A history of dermatological problems (e.g. psorias…
What they're measuring
1
Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE)
Timeframe: At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure).