MELASYL EFFICACY UNDER PART OF VISIBLE LIGHT (NCT06937515) | Clinical Trial Compass
CompletedNot Applicable
MELASYL EFFICACY UNDER PART OF VISIBLE LIGHT
Romania31 participantsStarted 2023-03-27
Plain-language summary
The study intends to evaluate the efficacy of an anti-melanogenesis active in different concentrations under part of visible Light \[400-450nm\] exposures and under full visible light \[400-700nm\] exposures.
It is carried out on cosmetic products for which the safety has been assured by a toxicologist, with the aim of confirming the efficacy of the products, which will be used by a large number of consumers under normal and reasonably foreseeable use conditions.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Healthy female or male volunteer from 18 to 65 years old
✓. Skin type III-IV according to the Fitzpatrick classification
✓. Average ITA° (Individual Typologic Angle calculated value) on the back between 18° and 34° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits
✓. Uniform skin color over the eight 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
. 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