A Phase 2, Randomized, Multicenter, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of VB-1953 Topical Gel When Applied Once or Twice Daily for 12 Weeks in Subjects With Moderate to Severe Inflammatory Facial Acne Vulgaris
试验速览
- 阶段
- 2 期
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Inflammatory lesion counts
研究概览
简要总结
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Dose-ranging Study in the Treatment of Acne Vulgaris,
详细描述
This will be a Phase 2, multicenter, randomized, double-blinded, dose-ranging, parallel arm comparison study in male and non-pregnant female subjects, 9 through 45 years of age (inclusive) with facial acne vulgaris. This dose-ranging study, intended to identify the dose(s), will consist of 7 study visits over 14 weeks:
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, Care Provider, Investigator)
盲法说明
Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 9 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or non-pregnant females 9 to 45 years of age (inclusive) at the time of consent/assent.
- •Have a clinical diagnosis of moderate to severe (Grade 3 or 4) facial acne vulgaris, as determined by the Investigator's Global Assessment (IGA).
- •Have 20 to 50 inflammatory lesions (papules, pustules) on the face.
- •Have 20 to 60 non-inflammatory lesions on the face.
排除标准
- •Has more than two (2) facial nodulocystic lesions.
- •Female subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Has active nodulocystic acne or acne conglobata, acne fulminans, or other forms of acne (e.g., acne mechanica). In the opinion of the Investigator, the subject has a skin pathology or other medical condition that is clinically significant (e.g., obesity) and will preclude participation in the study.
- •Has presence of any skin condition on the face (e.g., rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acnetiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis) in the opinion of the Investigator that could interfere with the diagnosis or assessment of acne vulgaris or evaluation of the investigational product (IP) or requires the use of interfering topical or systemic therapy.
- •Not willing to minimize or avoid natural and artificial sunlight exposure during treatment.
研究组 & 干预措施
VB-1953 topical gel - 2% BID
VB-1953 topical gel - 2% BID
干预措施: VB-1953 - 2% (Drug)
VB-1953 topical gel - 2% QD
VB-1953 topical gel - 2% QD
干预措施: VB-1953 - 2% (Drug)
VB-1953 topical gel- 0% (Vehicle) QD
VB-1953 topical gel- 0% (Vehicle) QD
干预措施: VB-1953 - 0% (Vehicle) (Drug)
VB-1953 Vehicle
VB-1953 topical gel- 0% (Vehicle) BID
干预措施: VB-1953 - 0% (Vehicle) (Drug)
结局指标
主要结局
Inflammatory lesion counts
时间窗: 12 weeks
Absolute Change from Baseline in inflammatory lesion counts in each treatment arm at Week 12.
次要结局
- Investigator's Global Assessment of Inflammatory Acne (IGA) score(12 weeks)
- Percent change in inflammatory lesion counts(12 weeks)