Phase 2 Study Randomized, Double-blind Study to Evaluate the Safety and Efficacy of 3 Doses of Doxycycline as Compared to Placebo in the Treatment of Moderate to Severe Facial Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population
研究概览
简要总结
Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Must be between 12 and 45 years of age.
- •Has a diagnosis of moderate to severe facial acne vulgaris with no more than two nodules on the face
排除标准
- •Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.
- •Has a history of pseudomembranous colitis or antibiotic-associated colitis.
- •Has a history of hepatitis or liver damage or renal impairment.
研究组 & 干预措施
Doxycyline 0.6 mg/kg/day
Doxycycline dosed at 40 mg/day to subjects of appropriate weights
干预措施: Doxycycline 0.6 mg/kg/day (Drug)
Doxycycline 1.2 mg/kg/day
Doxycycline dosed at 80 mg/day to subjects of appropriate weights
干预措施: Doxycycline 1.2 mg/kg/day (Drug)
Doxycycline 2.4 mg/kg/day
Doxycycline dosed at 160 mg/day to subjects of appropriate weights
干预措施: Doxycycline 2.4 mg/kg/day (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population
时间窗: Week 12
IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory \& inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score.
Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population
时间窗: Baseline to Week 12
Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules.
次要结局
- Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population(Baseline to Week 12)
- Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population(Baseline to Week 12)