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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.
The main objective of this study is to assess the efficacy of an anti-melanogenesis active in different concentrations under [400-450nm] exposures and under [400-700nm] in healthy volunteers by skin colorimetry (Delta E).
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melasyl at 1% and 0.5% versus its vehicle under High Energy Visible light or full visible light | A total of eight (8) zones of 3x3cm will be delineated on the back, four (4) zones per hemi-back (left and right) and exposed under UVA1+physical multilayer filter cut-off wavelengths under 400nm for [400-450nm] OR exposed under full visible light for [400-700nm]. - Three (3) zones per hemi-back will be treated with topical treatments during the 7 weeks of the study: IP1: Melasyl 1% in Bright Matte (893286 03) IP2: Melasyl 0.5% in Bright Matte (893286 02) IP3: Bright Matte vehicle (893286 P) - One (1) zone per hemi-back will not be treated (control NT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic topical products | Other | Cosmetic topical products efficacy evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin color measurement | Measurement of the skin color using Chromameter® (non-invasive assessment) between the exposed zone (ZE) and non-exposed zone (ZNE). | from Day 1 to Day 47. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual scoring of pigmentation | Visual evaluation of the pigmentation using L'Oreal pigmentation scale (0-13 points) | from Day 1 to Day 47. |
| Visual scoring of erythema | Visual evaluation of the erythema using L'Oreal pigmentation scale (0-13 points) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment | Safety will be assessed by recording Adverse Events, including cutaneous reactions (local intolerance), from the informed consent form signature date until the end of the study. | from Day 1 to Day 47. |
Inclusion Criteria:
Exclusion Criteria:
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Healthy male and female volunteers from 18 to 65 yo, with Fitzpatrick III and IV and an ITA° between 18° to 34° at screening.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIDP Romania | Budapest | 011607 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41142247 | Derived | Piffaut V, De Dormael R, Belaidi JP, Bertrand L, Passeron T, Bernerd F, Marionnet C. Topical prevention from high energy visible light-induced pigmentation by 2-mercaptonicotinoyl glycine, but not by ascorbic acid antioxidant: 2 randomized controlled trials. Front Pharmacol. 2025 Oct 9;16:1651068. doi: 10.3389/fphar.2025.1651068. eCollection 2025. |
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| from Day 1 to Day 47. |