Assessment of the Effects on the Skin Microbiome of Amending an Over-the-counter Eczema Product With Activated Oil (AO)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Atopic Dermatitis Severity Index (ADSI) score
研究概览
简要总结
This is a single-center, randomized, blinded, controlled trial assessing the effects on the skin microbiome in patients with eczema of amending a standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO)
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
- Single (Participant)
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
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female subjects aged who have a recent eczema itch flareup and/or pre-flare-up symptoms at screening as determined by visual analog scale (VAS).
- •Diagnosis of mild to moderate eczema (grade 3 - 7 on the Rajka-Langeland severity index).
- •Having a target lesion with an ADSI score of 6-12 and an erythema and pruritus subscore of ³2 (moderate).
- •Generally good health based on reported history.
- •Able to discontinue all medical and over the counter topical emollients, moisturizers, and / or other skin barrier lotions.
- •Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug.
- •Ability to administer topical medication and be willing to adhere to the study interventions.
- •Agreement to adhere to Lifestyle Considerations throughout the duration of the study.
排除标准
- •Pregnancy or lactation.
- •Any type of malignancy involving the Study Site Area (Lesion or Non-Lesion site) in the last 5 years.
- •Known allergy to hydrocortisone or topical antibiotic.
- •Topical or oral use of an antibiotic within the last 7 days prior to baseline clinical visit.
- •Bleach bathing in the 7 days prior to Baseline clinical visit.
- •Current use of Class I-III topical corticosteroids or systemic medications (e.g. Dupixent) potentially affecting eczema or the skin.
- •Surgeries or invasive medical procedures planned during course of study.
- •Suspected non-compliance or non-cooperation.
- •Intake of experimental drugs or experimental topical skin treatments within 30 days prior to study start.
- •Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or ability to complete the study.
- •Diagnosis of human immunodeficiency virus in medical history.
结局指标
主要结局
Atopic Dermatitis Severity Index (ADSI) score
时间窗: 14 days
Change in mean Atopic Dermatitis Severity Index (ADSI) score from baseline between the protocol and control arms by the 14-day application period. The ADSI comprises an assessment of erythema, pruritus, exudation, excoriation, and lichenification, each on a scale of 0 to 3 to give a maximum score of 15. The maximum score means a worsen condition.
Change in absolute abundance of S. aureus on target lesion site
时间窗: 14 days
Difference in reduction in absolute abundance of S. aureus on target lesion site compared to initial absolute abundance at target lesion site (Baseline measurement) between the protocol and control arms by 14-day application period of application period.
次要结局
- Change in Eczema Area and Severity Index (EASI) score(14 days)
- Change in relative abundance of S. aureus on non-lesion site(14 days)
- Change in absolute abundance of S. aureus and S. epidermidis on target lesion versus non-lesion site.(14 days)
- Change in Shannon Diversity Index between the target lesion site and non-lesion site(14 days)