NCT07598383招募中2 期
A Multicenter, Randomized, Double-blind, Vehicle Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 Gel in Adult Subjects With Mild to Moderate Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in EASI（Eczema area and severity index） from baseline
研究概览
简要总结
This is a multicenter, randomized, double-blind, vehicle controlled phase II clinical study to evaluate the efficacy and safety of VC005 gel in adult subjects 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
- 18 Years 至 —（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 18 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 judged by the investigator to have an unstable course of Atopic Dermatitis (AD) (spontaneous improvement or rapid deterioration) within 2 weeks before baseline;
- •Patients with skin lesions limited to the hands or feet at screening and baseline, with no prior history of involvement in other typical areas (such as the face or flexural folds);
- •Skin damage or abnormalities that may affect the evaluation of the investigational drug administration site (e.g., hyperpigmentation, large-area scars, tattoos, etc. at the affected site);
- •Presence of skin diseases at screening and baseline that may affect the evaluation of the administration site, including but not limited to: psoriasis, acne, skin cancer, generalized erythroderma, Netherton's syndrome, etc.;
- •Patients with a history of malignant tumors, with the exception of: cervical carcinoma in situ, non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma, or non-metastatic papillary thyroid carcinoma that have been completely resected with no evidence of recurrence for more than 5 years of survival.
研究组 & 干预措施
VC005 Dose B group
Experimental
干预措施: VC005 group (Drug)
VC005 Dose C group
Experimental
干预措施: VC005 group (Drug)
VC005 Placebo group
Placebo Comparator
干预措施: VC005 Placebo group (Drug)
VC005 Dose A group
Experimental
干预措施: VC005 group (Drug)
结局指标
主要结局
Changes in EASI（Eczema area and severity index） from baseline
时间窗: Week 4
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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