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The study intends to validate a protocol and define a positive reference to evaluate the efficacy of anti-pigmenting and depigmenting agents under part of visible Light exposures, between 400nm to 450nm.
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 antipigmenting or depigmenting agents under [400-450nm] exposure in healthy volunteers by skin colorimetry (Delta E).
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 differents actives compare to its respective vehicle | 8 topical cosmetics formulae applied on the back of volunteers, in mini-zones about 9cm2, at 4mg/cm2. Applied twice daily during 46 days: T1: Kopcinol 5% in inverse silicon T2: Vitamin C 7% in inverse silicon T3: Thiopyridinone 1% in Bright Matte T4: CD7414 0.5% in Hydro Alcoholic gel T5: Vehicle Inverse silicon T6: Hydro Alcoholic gel vehicle T7: Bright Matte vehicle |
|
| 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 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 50 yo, with Fitzpatrick III and IV and an ITA° between 18° to 32° at screening.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIDP Roumania | Bucharest | 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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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| from Day 1 to Day 47. |