Visible Light Exposures on Healthy Back Skin
Conditions
Keywords
Photoprotection, Sunscreen, Visible Light (VL), Pigmentation
Brief 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
Detailed description
The sunscreens usually used as photoprotectors are known to protect in the UV domain (UVB and UVA). However, until recently visible light (400-700 nm) was considered as devoid of any photobiological effects on cutaneous tissue. Over the last two decades, with the development of photodynamic therapies and various dermatological treatments using visible laser light, several studies have reconsidered the cutaneous effect of visible light on the skin, in particular the induction of pigmentation. This study intends to validate two simulators on visible light exposures with a referent solar formula on visible light protection.
Interventions
OTHERVisible Light Exposure - Treated zone - Left hemi-back
The treated zone located on the left side of the hemi-back was exposed to Visible Light with the simulator 1 to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application.
OTHERVisible Light Exposure - Treated zone - Right hemi-back
The treated zone located on the right side of the hemi-back was exposed to Visible Light with the simulator 2 to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application.
OTHERVisible Light Exposure - Untreated zone - Left hemi-back
The untreated zone located on the left side of the hemi-back was exposed to Visible Light with the simulator 1 to induce skin pigmentation (144J/cm2), as the same time as the treated zone.
OTHERVisible Light Exposure - Untreated zone - Right hemi-back
The untreated zone located on the right side of the hemi-back was exposed to Visible Light with the simulator 2 to induce skin pigmentation (144J/cm2), as the same time as the treated zone.
Sponsors
Cosmetique Active International
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy female or male volunteer from 18 to 50 years old 2. Skin type III-IV according to the Fitzpatrick classification 3. 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 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
1. Subject who is pregnant or lactating or who is planning to become pregnant during the study 2. Subject with BMI \> 30 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 swim 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 |
|---|---|---|
| Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE) | 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. | Pigmentation (Delta E - calculated values) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE) | 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. | Pigmentation : Individual Typologic Angle (ITA° - calculated value) based on Delta L\* and Delta b\* - calculated values) |
| Clinical investigator's assessment by using clinical scale | 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. | Visual scoring of pigmentation, using a pigmentation 14-point scale with 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 (Pronouced brown -), 12 (Pronouced brown), 13 (Pronouced brown +) Visual scoring of erythema, using an erythema 14-point scale with 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 (Pronouced pink -), 12 (Pronouced pink), 13 (Pronouced pink +) |
| Safety and Local Tolerance | From the informed consent signature date until the end of the study Day 12 | Safety was assessed by recording Adverse Events, including cutaneous reactions related to Visible Light exposures or Investigational Product (local intolerance). |
Countries
Romania
Outcome results
None listed