A Pilot Double-Blind Randomized Controlled Trial on the Efficacy and Safety of a Novel Skin Barrier Product Versus Petrolatum in Individuals With Skin Barrier Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Transepidermal water loss
研究概览
简要总结
The goal of this clinical trial is to learn if a novel barrier topical product works to treat barrier dysfunction in adults. It will also learn about the safety of the novel barrier topical product. The main questions it aims to answer are:
Does the novel barrier topical product improve skin hydration, skin sebum, redness, and pigmentation? Does it improve subjective dryness and itch? Researchers will compare the novel barrier topical product to petrolatum (a gold standard occlusive barrier repair agent) to see how they are comparable in treating skin barrier dysfunction.
Participants will:
Apply the novel barrier topical product or petrolatum twice a day for 28 days Visit the clinic once a week for checkups and tests Keep a diary of their application of the assigned product
详细描述
The goal of this randomized controlled trial is to determine the efficacy of a new barrier product (containing ceramide, virgin coconut oil, cholesterol) versus petrolatum in adults with skin barrier dysfunction (including mild to moderate psoriasis, atopic dermatitis, contact dermatitis, seasonal xerosis or clinically evident skin dryness).
The main questions it aims to answer are:
Primary Objective: In a pilot study, to compare the preliminary effectiveness of the test product (containing ceramides, cholesterol, coconut oil and monolaurin) versus petrolatum in improving skin barrier function, as measured by transepidermal water loss (using a Tewameter), skin hydration (using a Corneometer), skin lipids (using a Sebumeter) as well as skin erythema and pigmentation (using a Mexameter) over a four-week period.
Secondary Objectives:
To assess improvement in subjective symptoms (dryness, pruritus). To assess patient-reported outcomes, including comfort, ease of application, and overall satisfaction.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of mild skin barrier dysfunction, including:
- •Mild to moderate atopic dermatitis, defined as SCORAD ≤ 50, and/or not currently requiring topical corticosteroids or immunomodulators.
- •Mild to moderate chronic plaque psoriasis, defined as total body surface area (BSA) involved: ≤3% to 10%.
- •Contact dermatitis
- •Seasonal xerosis or clinically evident skin dryness
- •Symmetrical or bilateral test areas available (volar forearm)
- •Willing and able to provide informed consent and adhere to study procedures
排除标准
- •Failure to meet any of the above inclusion criteria
- •Severe atopic dermatitis or psoriasis requiring systemic or high-potency topical treatment
- •Use of corticosteroids, calcineurin inhibitors, biologics, or phototherapy within 2 weeks
- •Open wounds or evidence of secondary infection at test sites
- •Pregnant or breastfeeding women
- •Multiple nevi, tattoos, dense body hair in the test areas
- •Debilitated or immunocompromised subjects
- •Known or suspected hypersensitivity to the interventional product (or its ingredients) or petrolatum
- •Refusal or failure to comply with the schedule of visits at the test site.
结局指标
主要结局
Transepidermal water loss
时间窗: 28 days
using a Tewameter
Skin hydration
时间窗: 28 days
Using a Corneometer
Skin sebum
时间窗: 28 days
Using a Sebumeter
Skin erythema and pigmentation
时间窗: 28 days
Using a Mexameter
次要结局
- Change in dryness(28 days)
- Change in itch(28 days)
- Ease in application(28 days)
- Skin softness and smoothness(28 days)
- Satisfaction with product(28 days)
研究者
Dr. Vermen Verallo-Rowell
Past Chairman of Dermatology, Current Active Consultant
Makati Medical Center