Visible Light Exposure on Healthy Back Skin
Conditions
Keywords
pigmentation, visible light
Brief summary
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.
Detailed description
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: * To assess the local tolerance and safety of the products under VL exposure by recording adverse events and safety * To assess the safety of the different Investigational Products.
Interventions
None listed
Sponsors
L'Oreal
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* To be enrolled in this study, all subjects must satisfy all the following criteria at study entry: 1. Healthy female or male volunteer from 18 to 50 years old 2. 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 3. 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 4. Uniform skin color over the four zones (difference in ITA° between each zone should not be more than 4°) 5. Absence of freckles, naevi, hypo or hyper pigmented regions, hairs and marks of bronzing on the investigational area on the back 6. 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 7. Female of childbearing potential or menopausal female (with absence of menstruations for less than one year) willing to undergo urine pregnancy test 8. Subject willing and able to fulfil the study requirements and schedule 9. Subject informed about the study objectives and procedures, and able to understand them 10. 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: 1. Subject who is pregnant or lactating or who is planning to become pregnant during the study 2. Subject with BMI \> 30 except if, according to the investigator's judgement, the subject is able to follow the study procedure without compromising his/her health 3. Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study 4. Having used sunbeds or had excessive sun exposure of the investigational area within the 3 months before inclusion 5. Having sunburn (erythema) on the back 6. Dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems) 7. History of skin cancer 8. History of abnormal response to sun 9. Presence of recent suntan (according to Investigator opinion) or photo-test marks 10. History of allergy, hypersensitivity, or any serious reaction to any cosmetic product 11. Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator 12. Having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g. steroidal and non-steroidal anti-inflammatory drugs, corticoids, insulin, antihistamines, antihypertensive, antibiotics such as quinolone, tetracycline, thiazides, fluoroquinolones) 13. Having used within the month before inclusion any medication known to cause abnormal responses to UV exposure (e.g. vitamin A derivative, psoralen, aminolevulinic acid derivatives, etc.), or having planned to use these medications during the study 14. Having used within the 3 months before inclusion any depigmenting / whitening or pro-pigmenting topical treatments, or any systemic treatment that would interfere with the study assessments (anti-inflammatory drugs, corticoids, retinoids, hydroquinone, etc.) or having planned to use these treatments during the study 15. Having used, within the past 6 months, any physical treatment including laser or phototherapy (PUVA, IPL, PDT…) on the investigational area, or having planned to use these treatments during the study 16. Having planned to perform intensive sport (\> 5 hours per week) or to swim or to practice hammam/sauna during the study 17. Subject who declares to be deprived of freedom by administrative or legal decision 18. Subject who cannot be contacted by telephone in case of emergency 19. Subject having participated within the 30 days before inclusion or currently participating in another clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin color measurement with ITA° angle | From enrollment at Day 1 to the end of study at Day 12 | 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. |
| Skin pigmentation contrast | From enrollment at Day 1 to the end of study at Day 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual scoring of pigmentation | From enrollment at Day 1 to the end of study at Day 12 | A trained investigator will visually score the skin pigmentation, using L'Oreal pigmentation scale : 0 Absence 1. Barely visible 2. Very pale brown - 3. Very pale brown 4. Very pale brown + 5. Pale brown - 6. Pale brown 7. Pale brown + 8. Brown - 9. Brown 10. Brown + 11. Pronounced brown - 12. Pronounced brown 13. Pronounced brown + |
| Visual scoring of erythema | From enrollment at Day 1 to the end of study at Day 12 | A trained investigator will visually score the skin erythema, using L'Oreal erythema scale : 0 Absence 1. Barely visible 2. Very pale pink - 3. Very pale pink 4. Very pale pink + 5. Pale pink - 6. Pale pink 7. Pale pink + 8. Pink - 9. Pink 10. Pink + 11. Pronounced pink - 12. Pronounced pink 13. Pronounced pink + |
Countries
France
Outcome results
None listed