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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 to the placebo axilla to see if there is a difference in self-perceived odor and microbiome.
Participants will:
The study aims to evaluate the performance of NOBO, a yeast-based fermentation product (postbiotic) designed to control axillary odor, in controlling axillary odor and potentially impacting the skin microbiome. This study serves the purpose of validating the postbiotic's efficacy and de-risking future external clinical studies.
For this study, a total of 5-7 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.
On Day -7 to Day 0, each subject goes through a wash-in period with controlled washing with only unscented soap. For the first 4 days of the wash-in period, no antiperspirant is allowed. For the last 3 days of the wash-in period, no 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.
On Day 1 (AM), before showering the subject first performs the baseline microbiome sampling of both axilla. The subject then showers with unscented soap and performs the baseline self assessment of axillary odor. 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 self assesses odor and applies the deodorant to each axilla. On Day 2 (PM), the subject self assesses odor and applies the deodorant to each axilla. On Days 3-12, the subject applies the deodorants to each axilla twice daily (AM & PM) and self-assesses odor only once a day (PM). On Day 2 AM, Day 6 AM, and Day 12 AM, the subject samples the axilla for third party odor assessment. On Day 1 AM, Day 3 AM, Day 6 AM, Day 9 AM, and Day 12 AM, the subject performs microbiome sampling on each axilla. On Day 1 PM, Day 3 PM, Day 6 PM, Day 9 PM, and Day 12 PM, the subject self-assesses skin irritation on each axilla.
Observing a decrease in self perceived odor of the intervention (NOBO) axilla compared to the placebo axilla at any time point is the primary success criterion of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOBO aqueous deodorant | Experimental | The NOBO aqueous deodorant is composed of ≤7.2% yeast fermentation product (INCI: Yeast) and ≤ 40% ethanol in water. A dose is 0.48 mL per axilla for female subjects (3 actuations) or 0.64 mL per axilla for male subjects (4 actuations), delivered twice a day. |
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| Placebo aqueous deodorant | Placebo Comparator | The placebo deodorant is composed of ≤ 40% ethanol in water. The placebo deodorant contains the same concentration of ethanol as the NOBO aqueous deodorant. A dose is 0.48 mL per axilla for female subjects (3 actuations) or 0.64 mL per axilla for male subjects (4 actuations), delivered twice a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOBO Aqueous Deodorant | Other | The active ingredient in the NOBO aqueous deodorant is a yeast-based fermentation product (postbiotic) of the Starmerella genus. |
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| Measure | Description | Time Frame |
|---|---|---|
| Axillary odor self assessment (on 0-5 odor scale) | A 0 on the odor scale corresponds to "no axillary odor"; a 5 corresponds to "very strong axillary odor" | At baseline (before application), immediately after first application, Day 1 PM, Day 2 AM, and Day 2 PM; then once a day (PM) for Days 3-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Axillary odor self assessment (comparative) | Comparative assessment is simply a measurement of which axilla (left or right) smells worse. | At baseline (before application), immediately after first application, Day 1 PM, Day 2 AM, and Day 2 PM; then once a day (PM) for Days 3-12 |
| Axillary odor third party assessment (on 0-5 scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aylesse Sordillo, PhD | Principal Scientist at Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingdom | Brooklyn | New York | 11205 | United States |
No IPD will be shared.
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| ID | Term |
|---|---|
| D000089083 | Body Odor |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Split-axilla design: one axilla received intervention, other axilla receives placebo
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| Placebo Aqueous Deodorant | Other | The placebo deodorant is composed of ≤ 40% ethanol in water. |
|
A 0 on the odor scale corresponds to "no axillary odor"; a 5 corresponds to "very strong axillary odor." The third party odor assessor smells cotton rounds which the subject has rubbed on the axillae. |
| At Day 2 AM, Day 6 AM, and Day 12 AM |
| Axillary odor third party assessment (comparative) | Comparative assessment is simply a measurement of which axilla (left or right) smells worse. | At Day 2 AM, Day 6 AM, and Day 12 AM |
| Skin irritation (pain & redness) self assessment (0-4 Draize scale; 0-10 pain scale) | 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. | At baseline (before application), Day 3 PM, Day 6 PM, Day 9 PM, Day 12 PM |
| Axillary skin microbiome assessment via swab (qPCR to assess change in Staphylococcus genus) | Axillary skin swabs are sequenced via qPCR to assess change in the Staphylococcus genus, a key resident of the axillary microbiome. | At baseline (Day 1 AM), Day 3 AM, Day 6 AM, Day 9 AM, and Day 12 AM |