CTRI/2023/07/055190已完成Unknown
ong UVA and UV Day light in vivo exposures effects on skin pigmentation and skin quality: Comparison between Indian women presenting polluted ? profile versus a less polluted ? profile
’OREAL CHINA R&D Center0 个研究点目标入组 44 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Subject who has participated and completed in study POLLUVI 1_22-16120.
- •2.Healthy female volunteer from 18 to 45 years old (both inclusive).
- •3.Female of childbearing potential who is not sexually active, or who is using an effective contraceptive method.
- •4.Female of childbearing potential willing to undergo urine pregnancy test.
- •5.Average ITA° (Individual Typologic Angle calculated value) on the back between 20° and 41° at Inclusion, Baseline Evaluation and UV exposure visit (D1).
- •6.Skin type III or IV according to Fitzpatrick classification.
- •7.Uniform skin color all over on the 8 investigational zones (difference in ITA° between each zone should not be more than 4°) at Inclusion, Baseline Evaluation and UV exposure visit (D1).
- •8.Absence of freckles, naevi, scars, tattoos, hairs and marks of tanning on the investigational area on the back.
- •9.Non-smoker subject or having stopped at least 5 years ago.
- •10.Subject with an indoor work activity.
- •11.Subject willing and able to fulfil the study requirements and schedule.
- •12.Subject informed about the study objectives and procedures, and able to understand them.
- •13.Subject who has given written informed consent.
排除标准
- •1.Subject who is pregnant or lactating or who is planning to become pregnant during the study.
- •2.Menopausal female (with absence of menstruations for less than one year) or post-menopausal female (with absence of menstruations for more than one year).
- •3.Subject with BMI > 30.
- •4.Having planned UV exposure of the investigational area (sunlight or sunbeds) throughout the study.
- •5.Having used sunbeds or had excessive sun exposure of the investigational area within the 3 months before inclusion.
- •6.Having sunburn (erythema) on the back.
- •7.Dermatological disorders affecting the investigational area (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems.
- •8.History of skin cancer.
- •9.History of abnormal response to sun.
- •10.Presence of recent suntan (according to Investigator opinion) or photo-test marks on back.
- •11.History of allergy, hypersensitivity, or any serious reaction to any cosmetic product.
- •12.Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator.
- •13.Having used within the month before inclusion any systemic medication for more than 5 consecutive days (e.g., steroidal and non-steroidal anti-inflammatory drugs, corticoids, insulin, antihistamines, antihypertensive, antibiotics such as quinolone, tetracycline, thiazides, fluoroquinolones).
- •14.Having used within the month before inclusion any medication known to cause abnormal responses to UV exposure (e.g. vitamin A derivative, psoralen, aminolevulinic acid derivatives, etc.), or having planned to use these medications during the study.
- •15.Having used within the 3 months before inclusion any depigmenting / whitening or pro-pigmenting topical treatments, or any systemic treatment that would interfere with the study assessments (anti- inflammatory drugs, corticoids, retinoids, hydroquinone, etc.) or having planned to use these treatments during the study.
- •16.Having used, within the past 6 months, any physical treatment including laser or phototherapy (PUVA, IPL, PDT…) on the investigational area, or having planned to use these treatments during the study.
- •17.Having planned to perform intensive sport ( > 5 hours per week), swim, do sauna or hammam during the study.
- •18.Subject who declares to be deprived of freedom by administrative or legal decision.
- •19.Subject who cannot be contacted by telephone in case of emergency.
- •20.Subject having participated within the 30 days before inclusion or currently participating in another clinical study.
研究者
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