A Placebo-Controlled, Double-Blind, Bilateral Cosmetic Study With an Open Label Extension to Evaluate the Performance of a Cosmetic Product Designed to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AOBiome LLC
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance
研究概览
简要总结
The purpose of this study is to observe the performance of a cosmetic product, AO+Mist, on the appearance of arm skin in subjects with atopic dermatitis
详细描述
This is a single center, double-blind, bilateral, placebo-controlled study in subjects with Atopic Dermatitis affecting both sides of the body. Up to 20 subjects will be enrolled to participate.
Subjects will undergo a 2 week washout period prior to the Baseline procedure. Follwoing the Baseline visit assessments, subjects will be asked to apply "AO+ Mist" or placebo to the affected area of the arm twice a day (morning and night) for 30 days.
After the 30 day initial study period, subjects will automatically be rolled over to participate in the extension of the trial for another 30 days using only AO+Mist on the body parts affected by Atopic Dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
AO+ Mist (or placebo) are supplied in white 100mL metered spray bottles. Test products are blinded and labeled for application to the LEFT or RIGHT side of the body
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects ≥18
- •In good general health as determined by a thorough medical history i. Visible flexural dermatitis ii. Personal history of flexural dermatitis iii. Personal history of dry skin in the past 12 months
- •Subjects should have similar presentation and severity of AD on both arms
- •Ability to comprehend and comply with study procedures
- •Agree to commit to participate in the current protocol
- •Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)
排除标准
- •Female subjects who are pregnant or lactating or who are trying to conceive
- •Any clinically relevant abnormality identified on the screening history or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
- •Any skin condition which in the investigator's opinion may interfere with the evaluation of Atopic Dermatitis
- •Severe cases of AD that present with pustules and weeping and those cases that require urgent medical attention
- •Treatment with any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening period (this includes investigational formulations of marketed products, inhaled and topical drugs)
- •Hypersensitivity to AO+Mist or its components
- •Seropositive for human immunodeficiency virus (HIV) by medical history review at screening
- •Positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) by medical history review at screening
- •Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected test product non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)
研究组 & 干预措施
AO+Mist
AO+Mist
干预措施: AO+Mist (Other)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance
时间窗: Baseline-Day 30
次要结局
- Difference in Atopic Dermatitis EASI score(Baseline-Day 30)
- Difference in Skindex16 Quality of Life survey(Baseline-Day 30)
- Difference in Skindex 16 Quality of Life Survey during Extension Period(Day 30-60)
- Difference in EASI score during Extension Period(Day 30-60)