A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Different Doses of a Novel Tetracycline Compared to Placebo in the Treatment of Facial Acne Vulgaris, Study PR-10411
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit
研究概览
简要总结
To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.
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 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •if women of child-bearing potential, have a negative urine pregnancy test
- •Willing to use only a non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study
- •Male or female, 12-45 years of age with body weight between 52 and 88 kg
- •Diagnosis of acne vulgaris with:
- •20 to 50 inflammatory lesions (papules, pustules, and nodules) 30 to 100 noninflammatory lesions (open and closed comedones)
- •No more than 2 nodules on the face
- •Investigator's Global Assessment (IGA) score of moderate (3) to severe (4)
排除标准
- •Dermatological condition of face or facial hair that could interfere with clinical evaluations subjects who have used the following medications (topical refers only to the facial area) will not be eligible:
- •Within 1 week prior to randomization:
- •Medicated facial cleansers
- •Topical acne treatments (other than those listed below)
- •Within 4 weeks prior to randomization:
- •Topical retinoids
- •Topical anti-inflammatories and corticosteroids
- •Systemic antibiotics
- •Systemic acne treatments
- •Within 12 weeks prior to randomization:
- •Systemic retinoids
- •Systemic corticosteroids
- •Pseudomembranous colitis or antibiotic-associated colitis
- •Hepatitis, liver damage or renal impairment
研究组 & 干预措施
P005672-HCl approximately 0.75 mg/kg/day
One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks
干预措施: 50 mg P005672-HCl (Drug)
P005672-HCl approximately 0.75 mg/kg/day
One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks
干预措施: Placebo (Drug)
P005672-HCl approximately 1.5 mg/kg/day
Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks
干预措施: 50 mg P005672-HCl (Drug)
P005672-HCl approximately 3.0 mg/kg/day
Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks
干预措施: 100 mg P005672-HCl (Drug)
Placebo
Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit
时间窗: Baseline (Week 0) to Final Visit (Up to Week 12)
The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit
时间窗: Final Visit (Up to Week 12)
The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.
次要结局
- The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit(Baseline (Week 0) up to Week 12)
- The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit(Baseline (Week 0) up to Week 12)
- The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit(Baseline (Week 0) up to Week 12)
- The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit(Baseline (Week 0) up to Week 12)
- The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12(Baseline to Final Visit (Up to Week 12))