CompletedNot Applicable

Photoprotection Efficacy of a Sunscreen Under Visible Light Exposure by Using Two Different Simulators

Romania15 participantsStarted 2021-03-08

Plain-language summary

To assess the ability of a protected agent to prevent the pigmentation under visible light exposures (VL) using two different simulators 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 female or male volunteer from 18 to 50 years old
✓. Skin type III-IV according to the Fitzpatrick classification
✓. Average ITA° (Individual Typologic Angle calculated value) on the back between 18° and 32° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits
✓. Uniform skin color over the four zones (difference in ITA° between each zone should not be more than 4°)
✓. Absence of freckles, naevi, hypo or hyper pigmented regions, hairs and marks of bronzing on the investigational area on the back
✓. Female subject of childbearing potential, who is not sexually active, or using an effective contraceptive method\* for at least one month before the beginning of the study, and throughout the study or menopausal female (with absence of menstruations for less than one year) or post-menopausal female (with absence of menstruations for more than one year)
✓. Female of childbearing potential or menopausal female (with absence of menstruations for less than one year) willing to undergo urine pregnancy test
✓. Subject willing and able to fulfil the study requirements and schedule

Exclusion criteria

✕. Subject who is pregnant or lactating or who is planning to become pregnant during the study
✕. Subject with BMI \> 30
✕. Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study
✕. Having used sunbeds or had excessive sun exposure of the investigational area within the 3 months before inclusion
✕. Having sunburn (erythema) on the back
✕. Dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems
✕. History of skin cancer
✕. History of abnormal response to sun

What they're measuring

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, Day 5 (24 hours after each Visible Light exposure) and at Day 12.

Trial details

NCT IDNCT06796140

SponsorCosmetique Active International

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-04-09

View on ClinicalTrials.gov More Visible Light Exposures on Healthy Back Skin trials