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 Center1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2021年2月16日最近更新: 2022年3月16日

研究概览

简要总结

Objective:- To assess the efficacy of two topical test products on pollution-induced skin damages used over a period of 2 weeks, based on clinical, instrumental and subjective evaluations done at predetermined time points

Study Population:Healthy subjects in the age range of 18-50 years (both inclusive) including both Males and Females (26 males and 74 females) will be recruited for the study. Sufficient number of healthy male and female subjects of age 18-50 years (both inclusive) will be screened to include 100 subjects divided in twogroups. Each group will have 50 subjects (13 male and 37 female subjects, of which 15 subjects will belong to the non-sensitive skin type and remaining 35 subjects will have sensitive skin as assessed by Sting Test. Both groups will be balanced to have nearly equal/adequate representation of all skin types (Normal, Oily, Dry and Combination). Of the 50 subjects in each group, minimum 45 subjects should complete the study and 5 subjects are included additionally to account for drop outs if any.

Trial has been completed sucessfully with 98 completers

研究设计

研究类型: Interventional
分配方式: Other
盲法: Double Blind Double Dummy

入排标准

年龄范围: 18.00 Year(s) 至 50.00 Year(s)（—）
性别: All

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 investigatorâ€™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.