A Pilot Study on the Efficacy of 2% Cholesterol Cream in Preventing Transepidermal Water Loss and Clinical Symptoms in Mild to Moderate Atopic Dermatitis.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Atopic dermatitis is a common chronic inflammatory skin condition characterized by impaired skin barrier function, leading to increased transepidermal water loss (TEWL), dry skin, and itching. Restoration of the skin barrier is an important component of treatment. Cholesterol is a key lipid in the stratum corneum that plays a role in maintaining skin barrier integrity.
This study aims to evaluate the efficacy and safety of 2% cholesterol cream in improving skin barrier function and clinical symptoms in patients with mild to moderate atopic dermatitis aged 7-17 years. Participants will be randomly assigned to receive either 2% cholesterol cream or a placebo (cream base), applied twice daily for 12 weeks.
Outcomes will include measurements of transepidermal water loss (TEWL), skin hydration, skin pH, Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI), and pruritus numeric rating scale (NRS). The results of this study may support the use of cholesterol-containing topical formulations as a safe and effective treatment option for 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
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This study is double-blind. Participants and investigators assessing outcomes will be blinded to treatment allocation. The active and placebo creams are identical in appearance, packaging, and labeling.
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thai nationality
- •Aged between 7-17 years
- •Able to read and write Thai fluently
- •Clinically diagnosed with mild to moderate atopic dermatitis, with lesions located on both antecubital fossae, according to the Hanifin and Rajka criteria
- •Investigator's Global Assessment (IGA) score of 1-3
- •Eczema Area and Severity Index (EASI) score between 0.2-21
排除标准
- •Presence of other dermatologic conditions other than atopic dermatitis
- •Use of systemic immunosuppressive therapy (e.g., prednisolone, dupilumab, JAK inhibitors)
- •History of chronic infections such as hepatitis B, hepatitis C, herpes zoster, or tuberculosis
- •History of any malignancy
- •Pregnant or breastfeeding women, or those planning pregnancy during the study period