An Open Label Study to Document the Treatment Effect of 1 and 2% BPX-01 Minocycline Topical Gel in Moderate to Severe Inflammatory Non-nodular Acne Vulgaris (Protocol Number BPX-01-C04)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change From Baseline in Inflammatory Lesion Counts at Week 12
研究概览
简要总结
This is a multi center open label study intended to provide photo documentation and time to response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to severe non-nodular inflammatory acne vulgarism.
详细描述
This was a 12-week, multi-center, open label, two-arm study. Subjects will be assigned to treatment with 1% or 2% BPX-01 gel. Subjects will apply 1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be performed to assess efficacy. Photographs will be taken to document treatment effect.
Safety will be assessed with the vital signs, brief physical examination, clinical laboratory tests, cutaneous tolerance score, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, incidence of product related facial staining and collection of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe inflammatory non-nodular acne vulgaris
排除标准
- •female subject who is breastfeeding, pregnant or planning a pregnancy during the study
- •have other skin condition or disease that would interfere with the study
- •have had any prior treatment with minocycline
- •have a known or suspected allergy to tetracycline class products
- •have used OTC medications for the treatment of facial acne within the last 14 days
- •have used any prescription topical or oral medications for the treatment of facial acne in the last 28 days
- •have had a facial procedure (chemical peel, dermabrasion, laser, etc) within the last 8 weeks
研究组 & 干预措施
BPX-01 1%
BPX-01 1% minocycline topical gel
干预措施: Minocycline (Drug)
BPX-01 2%
BPX-01 2% minocycline topical gel
干预措施: Minocycline (Drug)
结局指标
主要结局
Change From Baseline in Inflammatory Lesion Counts at Week 12
时间窗: 12 weeks
difference in number of inflammatory lesions at week 12 as compared to baseline
次要结局
未报告次要终点