CTRI/2017/08/009383已完成未知
Clinical evaluation of efficacy of anti-pollution test products against the detrimental impact of pollution on the skin over a period of 8 weeks.
SkinMedica Inc AN ALLERGAN COMPANY0 个研究点目标入组 36 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Healthy female subjects aged 40-60 years old (both inclusive)
- •2 Occupationally be exposed to an excessively high concentration of air pollution (i.e.
- •outdoor workers)
- •3 Minimum grade 2 of crowâ??s feet wrinkles as per Skin aging atlas, volume IV Indian skin
- •type, by BAZIN & FLAMENT
- •4 Have at least grade 2 mild for overall skin damage, skin tone evenness, Tactile
- •Roughness and visible redness
- •5 Have lived in this high air pollution area for at least the past 2 years OR they must have
- •been occupationally exposed to this high air pollution for the past 2 years
- •6 Not be using fairness or antiaging or sunscreen creams/lotions (preferably about 60%
- •non users to be included)
- •7 Free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other
- •active skin conditions on the face and forearm
- •8 Agree not to use any other product/treatment/soap bar on their face and forearm during the study period
- •9 Agree not to carry out bleaching or any other procedures including facial etc. on face
- •and forearm during the study period
- •10 Agree to remove all jewellery on/around face (e.g., necklace, earrings, nose ring), during
- •VISIA imaging
- •11 Female subjects with child-bearing potential willing to undergo Urine Pregnancy Test
- •and to use acceptable methods of contraception (
- •The effective contraceptive methods include: sexually active females of childbearing
- •potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation),
- •or should use a medically accepted contraceptive regimen: systemic contraceptive (oral,
- •implant, injection), diaphragm or cervical cap with intravaginal spermicide, intravaginal
- •device, intrauterine device (IUD), condom with spermicide)
- •12 Willing to give a written informed consent
- •13 Ready to follow instructions and study restrictions during the study period
排除标准
- •1 Known hypersensitivity to any of the study products or constituents
- •2 Any significant skin pathology in the test area
- •3 Currently taking any medication including food supplements, which the Investigator
- •believes may influence the interpretation of the data
- •4 Having chronic illness or had major surgery in the last year
- •5 Undergoing any treatment of any skin condition on their face/body
- •6 Allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else
- •7 Females in pregnancy or lactation at the beginning of the study or planned during the
- •8 Participation in any other clinical trial up to 1 month prior to inclusion and during the
- •9 Any topical or systemic treatment(s) such as NSAIDs, corticosteroids, retinoids,
- •vitamins , etc. that, in the investigatorâ??s judgement, could interfere with the study
- •treatments / assessments, taken 2 weeks prior to inclusion and / or planned during the
- •10 Who have started, stopped or changed their hormonal treatment(s) (including
- •contraceptive pill) in the previous one month prior to the study
- •11 Any history of allergy to local anesthetic, keloids, hypertrophic scar, cardiac disorder,
- •bleeding tendency, vitiligo, herpes, local infection & epilepsy
- •Note: Upto 5 days of antibiotic use can be allowed during study period if required, based
- •on investigatorâ??s judgement.
研究者
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