Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this double-blind, randomized clinical trial is to evaluate the efficacy of anti-pigmentation cosmetic products in preventing skin pigmentation induced by High Energy Visible Light (HEVL) [400-450nm] in healthy volunteers (male and female, aged 18-60 years, Caucasian, phototypes III-IV).
The main questions it aims to answer are:
Can anti-pigmentation agents and/or HEV filters reduce HEV light-induced skin pigmentation, as measured by the Individual Typological Angle (Delta ITA°)? Can these products improve additional colorimetric parameters (Delta L*, a*, b*, Delta E) and clinical pigmentation and erythema scores (0-13 scale)? Are these formulations safe and well-tolerated under HEVL exposure? Researchers will compare seven cosmetic formulations (Products A to G) to an untreated exposed control zone to assess their ability to prevent HEVL-induced pigmentation.
Participants will:
Attend 36 visits over 7 weeks Receive standardized product applications (2 mg/cm²) on 7 test zones (3x3 cm) delineated on their back. One test zone will be not treated.
Be exposed to HEVL light [400-450nm] at 35 J/cm² over 4 consecutive days (Days 8-11) Undergo colorimetric measurements and clinical assessments of pigmentation and erythema at 13 time points
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product A | Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 |
| |
| Product B | Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 |
| |
| Product C | Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 |
| |
| Product D | Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 |
| |
| Product E | Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treated and exposed zones (cosmetic topical products applied) | Other | exposed to HEVL source to induce skin pigmentation (35 J/cm²) during 4 consecutive days (from Day 8 to Day 11) |
| Measure | Description | Time Frame |
|---|---|---|
| Skin color measurement | Measurement of the skin color using Chromameter® (non-invasive assessment) between the exposed zone (ZE) and the adjacent 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 erythema scale (0-13 points) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Emergent Adverse Events [Tolerability included] | 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:
Not provided
Not provided
Healthy male and female volunteers from 18 to 60 yo, with Fitzpatrick III and IV and an ITA° between 18° to 35° at screening.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIDP Biotechnology S.R.L | Bucharest | Romania |
Not provided
Not provided
Not provided
Not provided
| Product F | Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 |
|
| Product G | Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47 |
|
| Control | non treated zone |
|
| Untreated and exposed zone (no product applied) | Other | exposed to HEVL source to induce skin pigmentation (35 J/cm²) during 4 consecutive days (from Day 8 to Day 11) |
|
| From Day 1 to Day 47 |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided