A Randomized, Double-Blind, Placebo-Controlled, Split-Axilla, Proof-of-Concept Study to Evaluate the Efficacy of NOBO, a Novel Postbiotic, in Controlling Axillary Odor in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Axillary odor self assessment (on 0-5 odor scale)
研究概览
简要总结
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:
- be given a NOBO deodorant spray and a placebo deodorant spray (each assigned to one axilla)
- self assess body odor
- sample axilla with cotton round for 3rd party odor assessment
- sample axilla with a swab for skin microbiome analysis via qPCR
- self assess skin irritation
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: The subject is an adult between 18 and 70 y.o.
- •Skin health: The subject has no active skin conditions or lesions in the axillary region and no existing skin conditions (e.g., eczema, psoriasis, contact dermatitis).
- •Skin allergies: The subject has no known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
排除标准
- •Subject is pregnant, nursing, or planning to become pregnant in the next 6 months.
- •Subject is an insulin-dependent diabetic.
- •Subject has been diagnosed or treated for cancer in the past 5 years.
- •Subject is currently using or has not used in the past two weeks any systemic antibiotics.
- •Subject is currently using or used within the last month any topical medications, over-the-counter (OTC) or prescription products on the underarms.
- •Subject is currently taking or plans to take during the study any anti-inflammatory for a chronic condition (except 81 mg-Aspirin per day), immunosuppressant, antihistamine, or sedative medications (i.e. containing antihistamines like Tylenol PM, Nyquil, etc.).
- •Subject is currently participating in another underarm clinical trial. Subjects may participate in other studies as long as the same test sites are not used or are testing similar products.
研究组 & 干预措施
NOBO aqueous deodorant
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.
干预措施: NOBO Aqueous Deodorant (Other)
Placebo aqueous deodorant
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.
干预措施: Placebo Aqueous Deodorant (Other)
结局指标
主要结局
Axillary odor self assessment (on 0-5 odor scale)
时间窗: 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
A 0 on the odor scale corresponds to "no axillary odor"; a 5 corresponds to "very strong axillary odor"
次要结局
- Axillary odor self assessment (comparative)(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)(At Day 2 AM, Day 6 AM, and Day 12 AM)
- Axillary odor third party assessment (comparative)(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)(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)(At baseline (Day 1 AM), Day 3 AM, Day 6 AM, Day 9 AM, and Day 12 AM)