CTRI/2021/02/031335已完成未知
A double blind, randomized, parallel group study to evaluate the efficacy of anti-pollution product (s) on facial skin on healthy human subjects over a period of two weeks
ITC Limited ITC Life Sciences Technology Center0 个研究点目标入组 98 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
- 98
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 male and female subjects aged 18-50 years (both inclusive)
- •2.Having exposure of about 3-4 hrs daily to Blue light, hot air, smoke, extreme temperatures encountered indoors
- •3.Having sensitive skin or non-sensitive skin (as evaluated by stinging test)
- •4.Having skin sensitivity to environmental pollutants / Blue Light / Heat / extreme temperatures manifested as visible skin changes such as Pruritus, Erythema, Flaking, Stinging (this is applicable for subjects of sensitive skin only)
- •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 anti-aging or sunscreen creams/lotions
- •7.Free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face
- •8.Agree not to use any other product/treatment (eg: night cream) on their face during the study period (for male subjects shaving cream/foam/gel can be used for shaving purpose)
- •9.Agree not to carry out bleaching or any other procedures including facial etc. on face 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 on baseline visit and to use acceptable methods of contraception
- •12.Subject willing to provide written informed consent and is able to read, speak, write, and understand English or Hindi
- •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 (self-declared on screening visit and confirmed by UPT on baseline visit) or lactation at the beginning of the study or planned during the study
- •8.Participation in any other clinical trial up to 1 month prior to inclusion and during the study
- •9.Any topical or systemic treatment(s) such as NSAIDs, corticosteroids, retinoids, vitamins etc. that, in the investigatorââ?¬•s judgement, could interfere with the study treatments / assessments, taken 2 weeks prior to inclusion and / or planned during the study
- •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 NSAIDs, vitiligo, herpes, local infection & epilepsy
研究者
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