跳至主要内容
临床试验/CTRI/2020/02/023537
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

发起方
ITC Limited ITC Life Sciences Technology Centre

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