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The study intends to get knowledge on pigmentation induced by visible light on Asian/Chinese skin type and darker skin type, and to evaluate and to compare with a non-treated control zone and between them, the efficacy of photoprotective effect of different products after visible light exposure, between [400-700nm], on these skin types compared to Caucasian for whom the investigators already got knowledge.
The main objective of this study is:
- To assess the ability of protective agents to prevent the pigmentation under visible light exposures (VL) in healthy volunteers with different skin type (caucasian, asian and darker skin) by skin colorimetry (Delta E) and clinical evaluation.
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caucasian | 22 volunteers Caucasian skin with a skin phototype III or IV | ||
| Asian | 22 volunteers Asian skin with a skin phototype III-IV | ||
| Darker skin | 22 volunteers darker skin with a skin phototype VI |
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| Measure | Description | Time Frame |
|---|---|---|
| Skin color measurement with ITA° angle | The device Chromameter® (non-invasive assessment) will be used to measure the skin color, between the exposed zone (ZE) and non-exposed zone (ZNE), through the ITA° angle calculation, using formula [Arc Tangent ((L* - 50) / b*)] 180 / p. The L* defines the perceptual lightness from black at 0 to white at 100. The b* represents the blue-yellow opponents, with negative numbers toward blue and positive toward yellow. | From enrollment at Day 1 to the end of study at Day 12 |
| Skin pigmentation contrast | The device Chromameter® (non-invasive assessment) will be used to measure the skin contrast, between the exposed zone (ZE) and non-exposed zone (ZNE), through the Delta E calculation, using formula √ (ΔL*2+Δa*2+Δb*2)). The L* defines the perceptual lightness from black at 0 to white at 100. The a* axis is relative to the green-red opponent colors, with negative values toward green and positive values toward red. The b* represents the blue-yellow opponents, with negative numbers toward blue and positive toward yellow. | From enrollment at Day 1 to the end of study at Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual scoring of pigmentation | A trained investigator will visually score the skin pigmentation, using L'Oreal pigmentation scale : 0 Absence
| From enrollment at Day 1 to the end of study at Day 12 |
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Inclusion Criteria:
To be enrolled in this study, all subjects must satisfy all the following criteria at study entry:
Healthy female or male volunteer from 18 to 50 years old
Caucasian Skin type III-IV according to the Fitzpatrick classification OR Asian Skin type III-IV (chinese population) according to the Fitzpatrick classification OR Darker Skin type VI according to the Fitzpatrick classification
Average ITA° (Individual Typologic Angle calculated value) on the back between 24° and 36° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits, for Caucasian volunteers OR Average ITA° (Individual Typologic Angle calculated value) on the back between 24° and 36° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits, for Asian volunteers OR Average ITA° (Individual Typologic Angle calculated value) on the back less than -30° at screening and inclusion visits with an allowed difference of ± 2° between screening and inclusion visits, for Darker skin volunteers
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)
*Effective contraceptive methods: sexually active female of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intravaginal device, intrauterine device (IUD), condom with spermicide
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
Subject informed about the study objectives and procedures, and able to understand them
Subject who has given written informed consent
Exclusion Criteria:
If any following non-inclusion criterion applies, the subject must not be included in the study:
all
Healthy male and female volunteers from 18 to 50 yo, with Fitzpatrick III to VI and an ITA° between -30° to +36° at screening.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| L'Oréal | Aulnay-sous-Bois | 93600 | France |
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| Visual scoring of erythema | A trained investigator will visually score the skin erythema, using L'Oreal erythema scale : 0 Absence
| From enrollment at Day 1 to the end of study at Day 12 |