Study to Evaluate the Efficacy of Bite's Natural Deodorant

This is an open-label observational single-arm clinical trial to study the efficacy of a commercial deodorant and its effect on odor, clothing (stains), and quality of life. It is hypothesized that the deodorant marketed as Bite deodorant will mask bodily odor in participants, will not stain clothes, and improve the quality of life in trial participants.

Study Overview

• Status: Completed
• Conditions: Sweat; Underarm Odor
• Intervention / Treatment: Other: BITE Deodorant

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Agree to refrain from the use of any other deodorant or antiperspirant other than Bite for the study period
• Must be in good health (does not report any medical conditions asked in the screening questionnaire)
• Must be willing to comply with the requirements of the protocol
• Must be willing to add the deodorant to their daily routine
• Is willing and able to share feedback
• Shower daily, and put deodorant on the first thing in the morning (before sweating)
• If used deodorants previously must be a natural version

Exclusion Criteria:

• Unwilling to follow the routine of the protocol
• Currently participating in another research study
• Severe chronic conditions including oncological conditions, psychiatric disease, or other
• Females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
• Presence of self-reported armpit sensitivity
• Known to have severe allergic reactions
• Have known allergies to the trial product ingredients
• Currently using an antiperspirant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bite Deodorant; All 38 participants apply BITE deodorant daily for four weeks.	Other: BITE Deodorant; BITE natural Deodorant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in underarm odor	Survey-based assessment (0-5 scale) of changes in underarm odor	4 weeks
Changes in clothing staining	survey-based assessment (0-5 scale) of changes in clothing staining	4 weeks
Changes in reported quality of life	survey-based assessment (0-5 scale) of changes in reported quality of life	4 weeks

Collaborators and Investigators

• Sponsor: Kind Lab PBC.
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2021
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): March 11, 2022

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: perspiration; sweat; underarm odor
• Other Study ID Numbers: 20227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No