Studying the body odor controlling efficacy of products

Phase 2

Completed

• Registration Number: CTRI/2018/05/013996
• Lead Sponsor: ITC Life Science and Technology Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-06-15
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
malodour control efficacyTimepoint: Baseline (T0), 4 hrs (T1), 6 hrs (T2), 8 hrs (T3), 24 hrs (T4)