Healthy Volunteers, Hyperpigmentation, Skin Pigmentation
Conditions
Keywords
High Energy Visible Light (HEVL)
Brief summary
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
Interventions
OTHERTreated and exposed zones (cosmetic topical products applied)
exposed to HEVL source to induce skin pigmentation (35 J/cm²) during 4 consecutive days (from Day 8 to Day 11)
OTHERUntreated and exposed zone (no product applied)
exposed to HEVL source to induce skin pigmentation (35 J/cm²) during 4 consecutive days (from Day 8 to Day 11)
Sponsors
Cosmetique Active International
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Caucasian subjects 2. Male and female participants 3. Aged between 18 and 60 years old 4. Skin phototypes III-IV 5. Average ITA° on the back between 18° and 35° (± 2°) at screening and baseline/inclusion visit 6. Uniform skin color over the eight test zones (difference in ITA° between each zone ≤ 4°) 7. Untanned back (no UV exposure - natural or artificial - during the 2 months prior to inclusion) 8. No scar, spot, tattoo or excess hair on investigational zones 9. Subject having given written informed consent 10. Subjects able to read and understand study documents 11. Subjects with an official domicile 12. Subject covered by health insurance or social security 13. Female subjects of child-bearing potential using a safe method of contraception for at least 3 months prior to and throughout the study
Exclusion criteria
1. Pregnant, lactating, or planning to become pregnant during the study 2. Planned UV exposure (sunlight or sunbeds) of investigational zones throughout the study 3. Sunbed use or sun exposure of investigational zones within the 3 months prior to inclusion 4. Presence of sunburn (erythema) on the back 5. Dermatological disorders affecting investigational zones (naevi, freckles, excess hair, uneven skin tone, vitiligo, photodermatological problems) 6. History of skin cancer 7. History of abnormal response to sun 8. Presence of recent suntan or photo-test marks (per investigator opinion) 9. History of allergy, hypersensitivity, or serious reaction to any cosmetic product 10. Any concomitant medical condition that may interfere with the study (per investigator opinion) 11. Use of systemic medication for more than 5 consecutive days within the month prior to inclusion (e.g., steroids, antihistamines, antibiotics, vitamin A derivatives, psoralen) 12. Use of depigmenting, whitening or propigmenting topical treatments within the 3 months prior to inclusion 13. Physical treatment including laser or phototherapy (PUVA, IPL, PDT) within the past 6 months on investigational sites 14. Planned intensive sport (\> 5 hours per week) or swimming during the study 15. Participation in another clinical study within 30 days prior to inclusion 16. Deprived of liberty by adjunction or official decision 17. Unable to be contacted by phone in case of emergency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin color measurement | From Day 1 to Day 47 | Measurement of the skin color using Chromameter® (non-invasive assessment) between the exposed zone (ZE) and the adjacent non-exposed zone (ZNE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual scoring of pigmentation | From Day 1 to Day 47 | Visual evaluation of the pigmentation using L'Oreal pigmentation scale (0-13 points) |
| Visual scoring of erythema | From Day 1 to Day 47 | Visual evaluation of the erythema using L'Oreal erythema scale (0-13 points) |
Countries
Romania
Outcome results
None listed