NCT07592585招募中3 期
Phase III Clinical Study to Evaluate the Efficacy and Safety of VC005 in Adult and Adolescents With Mild to Moderate Atopic Dermatitis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
研究概览
简要总结
A multicenter, randomized, double-blind, vehicle controlled phase III clinical study to evaluate the efficacy and safety of VC005 in adults and adolescents with mild to moderate 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects fully understand this study, are able to follow the relevant procedures of the trial, voluntarily participate in the clinical trial, and sign the informed consent form (ICF);
- •The age requirement for signing the ICF is 12 years old or above, with no gender restrictions;
- •During screening, the diagnosis of atopic dermatitis should be met according to the Hanifin-Rajka criteria.
排除标准
- •Patients whose AD course is judged by the investigator as unstable(spontaneous improvement or rapid worsening) within 2 weeks prior to baseline;
- •At screening and baseline, lesions are localized only to the hands or feet, with no prior history of involvement of other typical areas (such as the face or flexural areas);
- •Skin damage or abnormalities that may affect the evaluation of the investigational drug administration site (e.g., pigmentation, extensive scarring, tattoos, etc., at the affected area);
- •At screening and baseline, presence of skin diseases that may affect the evaluation of the administration site, including but not limited to: psoriasis, acne, skin cancer, generalized erythroderma, Netherton syndrome, etc.
研究组 & 干预措施
VC005 Placebo group
Placebo Comparator
干预措施: VC005 Placebo (Drug)
研究者
研究点 (1)
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