Evaluation of the Efficacy of Anti-pigmentation Agents and/or Filters Under Part of Visible Light [400-450 nm] Exposures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Skin color measurement
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian subjects
- •Male and female participants
- •Aged between 18 and 60 years old
- •Skin phototypes III-IV
- •Average ITA° on the back between 18° and 35° (± 2°) at screening and baseline/inclusion visit
- •Uniform skin color over the eight test zones (difference in ITA° between each zone ≤ 4°)
- •Untanned back (no UV exposure - natural or artificial - during the 2 months prior to inclusion)
- •No scar, spot, tattoo or excess hair on investigational zones
- •Subject having given written informed consent
- •Subjects able to read and understand study documents
- •Subjects with an official domicile
- •Subject covered by health insurance or social security
- •Female subjects of child-bearing potential using a safe method of contraception for at least 3 months prior to and throughout the study
排除标准
- •Pregnant, lactating, or planning to become pregnant during the study
- •Planned UV exposure (sunlight or sunbeds) of investigational zones throughout the study
- •Sunbed use or sun exposure of investigational zones within the 3 months prior to inclusion
- •Presence of sunburn (erythema) on the back
- •Dermatological disorders affecting investigational zones (naevi, freckles, excess hair, uneven skin tone, vitiligo, photodermatological problems)
- •History of skin cancer
- •History of abnormal response to sun
- •Presence of recent suntan or photo-test marks (per investigator opinion)
- •History of allergy, hypersensitivity, or serious reaction to any cosmetic product
- •Any concomitant medical condition that may interfere with the study (per investigator opinion)
- •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)
- •Use of depigmenting, whitening or propigmenting topical treatments within the 3 months prior to inclusion
- •Physical treatment including laser or phototherapy (PUVA, IPL, PDT) within the past 6 months on investigational sites
- •Planned intensive sport (> 5 hours per week) or swimming during the study
- •Participation in another clinical study within 30 days prior to inclusion
- •Deprived of liberty by adjunction or official decision
- •Unable to be contacted by phone in case of emergency
研究组 & 干预措施
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
干预措施: Treated and exposed zones (cosmetic topical products applied) (Other)
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
干预措施: Treated and exposed zones (cosmetic topical products applied) (Other)
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
干预措施: Treated and exposed zones (cosmetic topical products applied) (Other)
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
干预措施: Treated and exposed zones (cosmetic topical products applied) (Other)
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
干预措施: Treated and exposed zones (cosmetic topical products applied) (Other)
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
干预措施: Treated and exposed zones (cosmetic topical products applied) (Other)
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
干预措施: Treated and exposed zones (cosmetic topical products applied) (Other)
Control
non treated zone
干预措施: Untreated and exposed zone (no product applied) (Other)
结局指标
主要结局
Skin color measurement
时间窗: 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).
次要结局
- Visual scoring of pigmentation(From Day 1 to Day 47)
- Visual scoring of erythema(From Day 1 to Day 47)