A Multi-Center, Controlled Clinical Trial to Assess the Effects of Topical Lotions on Changes in the Skin Microbiome and Associations With Itch
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Microbiome Composition Changes in Lesion Skin - Baseline to Day 14
研究概览
简要总结
This was a multi-center, 14-day clinical use study with a 7-day regression period, being conducted to assess the changes in the skin microbiome with two moisturizers in female and male subjects 16-50 years of age with mild to moderate eczema that experienced a recent itch flare up.
详细描述
In this study, subjects were divided into two groups, one group was supplied with a test product containing an over-the-counter (OTC) drug monographed ingredient for treatment of eczema. The other group was supplied with a cosmetic test product which is a standard dry skin daily moisturizer. Both groups were also provided with a cosmetic test cleanser to use in place of their normal cleanser. Subjects used the products for 14 days, followed by a 7-day regression period (no product use).
Subjects were assessed at Baseline and at Day 1, Day 3, Day 7, and Day 14 of product use. They were assessed again 7 days after stopping product use. Only the group provided with the test product containing the monograph ingredient for treatment of eczema were assessed for eczema endpoints after the Baseline visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate eczema, as determined by the investigator (score of 2.0-7.5 on Rajka-Langeland severity index).
- •Has 1 target lesion, as determined by the investigator (score of 6-12 on Atopic Dermatitis Severity Index (ADSI) and sub-score of at least 2 on erythema and pruritus).
- •Experienced a recent itch flare up and is experiencing pre-flare up symptoms at screening.
- •Did not use moisturizer on the face and body for 3 days prior to screening.
- •Has a score of at least 4.0 on Visual Analog Scale (VAS) Itch Assessment scale at baseline.
- •Generally in good health.
- •Willing to stop using all topical emollients, moisturizers, and/or other skin barrier creams and/or emulsion treatments for the eczema condition during the test period.
- •Willing and able to follow all study directions, including avoiding excessive sun exposure (including tanning beds), and to commit to all follow up visits for the duration of the study.
- •Completed informed consent/assent process and signed photograph release.
- •Must agree to practice a medically acceptable form of birth control.
排除标准
- •Known allergies or sensitivities to test product ingredients.
- •Severe eczema.
- •Using a therapeutic (over the counter or prescription) body wash that contains an active ingredient for eczema.
- •Has a health condition or skin condition that the study investigator thinks could increase risk to the subject or confuse study results (e.g. immune deficiency disorders).
- •Has been using that the study investigator thinks could increase risk to the subject or confuse study results (e.g. corticosteroids, immunosuppressive medications).
- •Currently participating in another study.
- •Subjects who have clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections.
- •Has any planned surgery and/or invasive medical procedures scheduled during the course of the study.
研究组 & 干预措施
OTC Eczema Moisturizer Regimen
Subjects who were assigned to use an over-the-counter (OTC), oatmeal-containing eczema therapy moisturizing cream. The product is classified as an OTC monograph drug.
干预措施: OTC Eczema Moisturizer Regimen (Drug)
Cosmetic Moisturizer Regimen
Subjects who were assigned to use a non-fragranced, dry skin daily moisturizer classified as a cosmetic (i.e. non-OTC).
干预措施: Cosmetic Moisturizer Regimen (Other)
结局指标
主要结局
Microbiome Composition Changes in Lesion Skin - Baseline to Day 14
时间窗: 2 weeks
Changes in the composition (abundance and diversity) of the microbiome communities present on the lesional skin from Baseline to Day 14. The microbiome of the skin of interest was sampled using a sterile swab, sequenced to amplify genomic regions, and analyzed using standard protocols to determine associated organisms, both known and novel, between the two time points.
次要结局
- Skin pH - Change - Baseline to Day 7(1 week)
- Skin pH - Change - Baseline to Day 3(3 days)
- Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 14(2 weeks)
- Microbiome Composition Changes in Lesion Skin - Baseline to Day 7(1 week)
- Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 7(1 week)
- Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 3(3 days)
- Microbiome Composition Changes in Lesion Skin - Baseline to Day 3(3 days)
- Microbiome Composition Changes in Lesion Skin - Baseline to Day 1(1 day)
- Microbiome Composition Changes in Lesion Skin - Regression Baseline to Day Regression Day 7(1 week)
- Skin Transepidermal Water Loss (TEWL) - Change - Baseline to Day 1(1 day)
- Skin Hydration - Change - Baseline to Day 1(1 day)
- Eczema Area Severity Index (EASI) - Change - Baseline to Day 14(2 weeks)
- Skin pH - Change - Baseline to Day 1(1 day)
- Skin pH - Change - Regression Baseline to Regression Day 7(1 week)
- Skin Transepidermal Water Loss (TEWL) - Change - Regression Baseline to Regression Day 7(1 week)
- Skin pH - Change - Baseline to Day 14(2 weeks)
- Skin Hydration - Change - Baseline to Day 3(3 days)
- Eczema Area Severity Index (EASI) - Change - Baseline to Day 3(3 days)
- Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 1(1 day)
- Skin Hydration - Change - Baseline to Day 14(2 weeks)
- Skin Hydration - Change - Baseline to Day 7(1 week)
- Skin Hydration - Change - Regression Baseline (Day 14) to Regression Day 7 (Day 21)(1 week)
- Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 7(1 week)
- Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 3(3 days)
- Eczema Area Severity Index (EASI) - Change - Baseline to Day 7(1 week)
- Atopic Dermatitis Severity Index (ADSI) - Change - Baseline to Day 14(2 weeks)
- Eczema Area Severity Index (EASI) - Change - Baseline to Day 1(1 day)
- Eczema Area Severity Index (EASI) - Change - Regression Baseline to Regression Day 7(1 week)
- Atopic Dermatitis Severity Index (ADSI) - Change - Regression Baseline to Regression Day 7(1 week)