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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Axillary odor self assessment (comparative)
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 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
详细描述
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.
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 deodorant
The NOBO deodorant is composed of ≤2.6% yeast fermentation product and 10% 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 postbiotic (Other)
Placebo deodorant
The placebo deodorant is composed of 10% ethanol in water. The placebo deodorant contains the same concentration of ethanol as the NOBO 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 (Other)
结局指标
主要结局
Axillary odor self assessment (comparative)
时间窗: 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.
次要结局
- Axillary odor self assessment (on a 0-5 scale)(at baseline (before application), immediately after first application, Day 1 PM, Day 2 PM, and Day 3 PM)
- Skin irritation (pain & redness) self assessment (0-4 Draize scale; 0-10 pain scale)(at baseline (before application) and Day 3 PM)