Kingdom
Brooklyn, New York, 11205, United States
NCT Number: NCT07726238
The goal of this clinical trial is to evaluate the performance of NOBO, a yeast-based fermentation product (postbiotic) designed to control axillary odor, in controlling axillary odor in healthy male and female adults age 18 - 70 with confirmed self-perception of body odor. The main question it aims to answer is: Does NOBO decrease self-perceived odor of the intervention axilla compared to the placebo axilla at any time point? Researchers will compare the intervention axilla odor score to the placebo axilla odor score to see if there is a difference in self-perceived odor. Participants will:
* be given a NOBO deodorant spray and a placebo deodorant spray (each assigned to one axilla) * self assess body odor * self assess skin irritation
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Brooklyn, New York, 11205, United States
The study aims to evaluate the performance of NOBO, a yeast-based fermentate designed to control axillary odor, in controlling axillary odor. This third efficacy study of NOBO serves the purpose of validating the fermentate's efficacy and de-risking future external clinical studies.
For this study, a total of 14 subjects will be recruited based on the recruitment requirements. The target population for this study is healthy male and female adults age 18 - 70 with no existing skin conditions (e.g., eczema, psoriasis, contact dermatitis) and no known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs, with confirmed self-perception of body odor. All assessments are conducted via electronic surveys through an internal data collection platform.
On Day -1 to Day 0, each subject goes through a wash-in period with controlled washing with only unscented soap; no use of underarm product is allowed.
Participants are randomly assigned a treatment axilla: either left or right. One axilla (intervention axilla) will receive NOBO for the full duration of the intervention period. The other axilla (control axilla) will receive a placebo for the full duration of the study.
Throughout the study, participants perform self-assessment of odor that includes assessing which axilla has stronger odor and rating the odor of each axilla using a standard odor rating scale (0-5). On Day 1 (AM) the subject performs the baseline self assessment of axillary odor and skin irritation. The subject then applies the deodorants to each axilla and self assesses odor immediately after the first application. On Day 1 (PM), ~12 hours after Day 1 AM application, the subject self assesses odor and applies the deodorants to each axilla again. On Day 2 (AM), the subject applies the deodorant to each axilla. On Day 2 (PM), the subject self assesses odor and applies the deodorant to each axilla. On Day 3, no underarm washing is allowed. On Day 3 (AM), the subject applies the deodorant to each axilla. On Day 3 (PM), the subject self assesses odor and skin irritation on each axilla.
Observing a decrease in self perceived odor of the intervention (NOBO) axilla compared to the placebo axilla at any post-baseline timepoin
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The active ingredient in the NOBO deodorant is a yeast-based fermentation product (postbiotic) of the Starmerella genus.
The placebo deodorant is composed of 10% ethanol in water
Time frame: At baseline (before application), immediately after first application, Day 1 PM, Day 2 PM, and Day 3 PM
Comparative assessment is simply a measurement of which axilla (left or right) smells worse.
Time frame: at baseline (before application), immediately after first application, Day 1 PM, Day 2 PM, and Day 3 PM
A 0 on the odor scale corresponds to "no axillary odor"; a 5 corresponds to "very strong axillary odor"
Time frame: at baseline (before application) and Day 3 PM
A 0 on the Draize scale corresponds to no redness/edema; a 4 on the Draize scale corresponds to severe redness/edema. On the 0-10 pain scale, 0 = No pain at all, 5 = Moderate pain, 10 =Severe or unbearable pain.
Kingdom
Industry
A Randomized, Double-Blind, Placebo-Controlled, Split-Axilla, Proof-of-Concept Study #3 to Evaluate the Efficacy of NOBO, a Novel Postbiotic, in Controlling Axillary Odor in Healthy Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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