CTRI/2018/05/013996
Completed
Phase 2
Evaluating Dermatological Safety and Malodor Control Efficacy of Test Products On Healthy Human Subjects Of Varied Skin Types
ITC Life Science and Technology Centre0 sites100 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ITC Life Science and Technology Centre
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Equal distribution of gender (1:1\)
- •2 Equal distribution of different skin types: Combination, Dry, Normal, Oily, Sensitive (As per modified Baumannââ?¬•s Skin Type questionnaire)
- •3 Age: 18 to 45 yrs
- •4 Volunteers in generally good health and not undergoing medical treatment
- •5 Volunteers without any cuts, marks and open wounds on both axillae
- •6 Volunteers free of any obvious infection of skin as determined by dermatologist
- •7 Volunteers with a malodor score above 2\.5 on a scale of 0\-5 with normal activity during the day with an odour difference of \<1 between the right and left axillae as per the olfactory panel.
- •8 Volunteers willing to give a written informed consent
- •9 Volunteers willing to abide by the study requirements and visit the site for regular follow up.
Exclusion Criteria
- •1 Volunteers with known allergies or sensitivities to cosmetic products or its components like fragrances, preservatives etc
- •2 Volunteers who are currently undergoing / had undergone dermatological treatments or procedures within the last 1 month
- •3 Volunteers with pre\-existing or dormant dermatologic conditions (e.g. psoriasis, rosacea, rashes, eczema, many and/or severe excoriations etc.) that could interfere with the study outcome as determined by the investigator
- •4 Volunteers with an extremely high ( \>4\.5\) or extremely low ( \<2\.5\) malodor score as per the olfactory panel
- •5 Volunteers with wide difference in malodor scores across right and left axillae ( \>1\).
- •6 Volunteers with scars which could interfere with expert grading
- •7 Volunteers who are nursing or pregnant (Self declaration / Urine pregnancy test)
- •8 Volunteers unwilling to abstain from alcohol consumption and smoking for the study duration
- •9 Volunteers viewed by the investigator as not being able to complete the study
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
Studying the body odor controlling efficacy of products On Healthy Human SubjectsCTRI/2019/03/018090ITC Life Science and Technology Centre100
Completed
Phase 2
To check irritation potential of the given samples (Patch test)CTRI/2019/11/022065ITC LIMITED ITC Life Sciences and Technology CENTRE33
Completed
Phase 1
Evaluation of Safety & Efficacy of Bath AccessoriesCTRI/2018/03/012306ITC Life Sciences Technology Centre24
Recruiting
Phase 2
Dermatological safety Study of Cosmetics on healthy human volunteersCTRI/2024/01/061557Pure Born Family Care
Completed
Not Applicable
Dermatological safety Study of Cosmetics on healthy human volunteersCTRI/2023/08/056655Sreedhareeyam Farmherbs India P Ltd50