To check the efficacy of cosmetic products in offering protection against skin stress inducers including pollutio
- Registration Number
- CTRI/2021/02/031335
- Lead Sponsor
- ITC Limited ITC Life Sciences Technology Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 98
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of two topical test <br/ ><br>products on <br/ ><br>pollution-induced skin damages used over a <br/ ><br>period of 2 weeks, based on clinical, <br/ ><br>instrumental and subjective evaluations done at <br/ ><br>predetermined time pointsTimepoint: To assess the efficacy of two topical test <br/ ><br>products on pollution-induced skin damages used over a <br/ ><br>period of 2 weeks, based on clinical, <br/ ><br>instrumental and subjective evaluations done at <br/ ><br>predetermined time points
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable