None listed
Conditions
Interventions
Intervention1: BU-07: Baseline (T0), 4 hrs (T1), 6 hrs (T2), 8 hrs (T3), 24 hrs (T4)Dermatologists Visual Assessment of Axillary Skin for Irritation ,
Olfactory Panel Assessment, Subjects� Sel
Sponsors
ITC Life Science and Technology Centre
Eligibility
Inclusion 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 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
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 ( 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the dermatological safety and malodour control efficacy of the investigational productsTimepoint: Baseline (T0), 4 hrs (T1), 6 hrs (T2), 8 hrs (T3) and 24 hrs (T4) | — |
Secondary
| Measure | Time frame |
|---|---|
| malodour control efficacyTimepoint: Baseline (T0), 4 hrs (T1), 6 hrs (T2), 8 hrs (T3), 24 hrs (T4) | — |
Countries
India
Contacts
Public ContactUma Ayachit
The KETs Scientific Research Centre, Cosmetology Division
Outcome results
None listed