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To evaluate the protective effect of seven sunscreens on the pigmentation induced by visible light in comparison to an untreated control zone in healthy volunteers
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.
The study intends 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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product 1 | The test product 1 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4). |
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| Product 2 | The test product 2 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4). |
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| Product 3 | The test product 3 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4). |
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| Product 4 | The test product 4 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4). |
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| Product 5 | The test product 5 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visible Light Exposure - Treated zones | Other | The treated zones were exposed to Visible Light to induce skin pigmentation (144J/cm2), 15 to 30 minutes after application. |
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| Measure | Description | Time Frame |
|---|---|---|
| Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE) | Pigmentation (Delta E - calculated values) | At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical investigator's assessment by using clinical scale | 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 +) |
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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 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)
*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:
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Healthy male and female volunteers from 18 to 50 years old with phototype III to IV according to the Fitzpatrick scale and with an ITA° between 18° to 32° at Screening
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIDP Biotechnology S.R.L | Bucharest | 011607 | Romania |
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| Product 6 | The test product 6 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4). |
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| Product 7 | The test product 7 was applied (2 mg/cm²) on the attributed zone according to the randomization list. The application was done during 4 consecutive days (From Day 1 to Day 4). |
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| Untreated zone | non-treated control zone |
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| Visible Light Exposure - Untreated zone | Other | The untreated zone was exposed to Visible Light to induce skin pigmentation (144J/cm2), as the same time as the treated zones. |
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| At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure). |
| Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE) | Pigmentation : Individual Typologic Angle (ITA° - calculated value) based on Delta L* and Delta b* - calculated values) | At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure). |
| Safety / Local Tolerance | Safety was assessed by recording Adverse Events, including cutaneous reactions (local intolerance). | From the informed consent signature date until the end of the study (Day 5) |
| Biophysical non-invasive assessment of skin color by using Chromameter® between the exposed zone (ZE) and non-exposed zone (ZNE) | Erythema (Delta a* - calculated value) | At Day 1 before treatment (baseline), then Day 2, Day 3, Day 4 and Day 5 (24 hours after each Visible Light exposure) |