Effectiveness and Tolerability of an Emollient 'Plus' Compared to Urea 10% in Patients With Mild-moderate Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- EASI (Eczema Area and Severity Index)
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness and tolerability of an Emollient Aqua Posae + Microesyl compared to urea 10% in patients with mild-moderate atopic dermatitis The main question it aims to answer is:
" To evaluate the effectiveness and tolerability of an Emollient Aqua Posae + Microesyl compared to urea 10% in patients with mild-moderate atopic dermatitis age 18 years and above". Moisturizer application will be performed twice daily, 3 minutes after bathing, with a standardized dose using the Finger Tip Unit (FTU) method.
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)
盲法说明
The moisturizer codes will be blinded (double-blind) until all study phases are completed. This ensures that the participants, investigators, and outcomes assessors are unaware of which intervention each participant is receiving during the study. This helps to minimize potential bias in the evaluation of the treatment outcomes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged ≥18 years
- •AD patients who meet the criteria for AD diagnosis according to the Hanifin-Rajka criteria.
- •Patients with mild-moderate AD according to the SCORAD index.
- •Patients who have AD lesions on the hands and/or feet.
- •Patients with good general condition.
- •Patients are willing to participate in the study and sign the informed consent.
排除标准
- •Pregnant and lactating patients.
- •Patients with a history of allergies to ingredients contained in moisturizers
- •Patients who clinically have other skin diseases such as psoriasis, seborrheic dermatitis, contact dermatitis or AD with secondary infections that can affect the SCORAD index parameters, skin hydration, skin pH and side effects on the skin area being assessed.
- •Patients receiving topical or systemic immunomodulatory and/or immunosuppressant therapy.
- •Patients receiving topical and/or systemic antibiotic therapy
- •Patients receiving systemic antihistamine therapy (patients who require antihistamines during the study will be recorded on the observation sheet)
结局指标
主要结局
EASI (Eczema Area and Severity Index)
时间窗: Through study completion, 12 week
* The EASI is a tool that measures the extent and severity of atopic dermatitis lesions. * The EASI score ranges from 0 to 72, with higher scores indicating more severe disease. 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe
PVAS (Pruritus Visual Analog Scale)
时间窗: Through study completion, 12 week
* The PVAS is a 100 mm visual analog scale that assesses the severity of pruritus (itching) experienced by the patient. * The PVAS ranges from 0 (no itch) to 100 (worst imaginable itch).
SCORAD (Scoring Atopic Dermatitis)
时间窗: Through study completion, 12 week
* The SCORAD is a composite score that evaluates the extent and severity of atopic dermatitis. * The SCORAD scale ranges from 0 to 103, with higher scores indicating more severe disease. The ranges of the SCORAD (0-25 for 'mild' disease, and 25-50 for 'moderate' disease, \>50 for severe disease)
DLQI (Dermatology Life Quality Index)
时间窗: Through study completion, 12 week
* The DLQI is a questionnaire that assesses the impact of skin diseases on a patient's quality of life. * The DLQI score ranges from 0 to 30, with higher scores indicating a greater impairment of quality of life.
次要结局
- Transepidermal Water Loss (TEWL)(Through study completion, 12 week)
- Skin pH(Through study completion, 12 week)
- Skin Hydration(Through study completion, 12 week)