Studying the body odor controlling efficacy of products On Healthy Human Subjects

Phase 2

Completed

• Registration Number: CTRI/2019/03/018090
• 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: 2019-04-28
• 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)