CTRI/2020/02/023537Other未知
A DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THEEFFICACY AND TOLERABILITY OF ANTI-POLLUTION PRODUCT (S) ON FACIAL SKIN OF HEALTHY HUMAN SUBJECTS OVER A PERIOD OF TWO WEEKS
ITC Limited ITC Life Sciences Technology Centre0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- Other
- 发起方
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 old (both inclusive)
- •2. Occupationally be exposed to an excessively high concentration of air pollution (i.e.
- •outdoor workers)
- •3. Having sensitive skin or normal skin (as evaluated by stinging test)
- •4. 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
- •5. Not be using fairness or antiaging or sunscreen creams/lotions
- •6. Free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face
- •7. 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)
- •8. Agree not to carry out bleaching or any other procedures including facial etc. on face
- •during the study period
- •9. Agree to remove all jewellery on/around face (e.g., necklace, earrings, nose ring) during
- •VISIA imaging
- •10. Female subjects with child-bearing potential willing to undergo Urine Pregnancy Test on baseline visit and to use acceptable methods of contraception
- •11. Subject willing to provide written informed consent and is able to read, speak, write, and
- •understand English or Hindi
- •12. 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
- •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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