A Study of the Safety, Tolerability and Preliminary Efficacy of DRM01B Topical Gel in Healthy Volunteers and Subjects With Acne Vulgaris
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 12
- 主要终点
- Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 in Phase 2a
研究概览
简要总结
This is a Phase 1/2a study.
The purpose of Phase 1 was to evaluate the safety and tolerability of DRM01B Topical Gel in 6 healthy volunteers.
The purpose of Phase 2a was to assess the safety, tolerability and preliminary efficacy of DRM01B Topical Gel compared to vehicle in subjects with acne vulgaris on the face.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Phase 1
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers
干预措施: Olumacostat Glasaretil Gel, 7.5% (Drug)
Phase 2a
Olumacostat Glasaretil Gel, 7.5%, or Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
干预措施: Olumacostat Glasaretil Gel, 7.5% (Drug)
Phase 2a
Olumacostat Glasaretil Gel, 7.5%, or Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
干预措施: Olumacostat Glasaretil Gel, Vehicle (Other)
结局指标
主要结局
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 in Phase 2a
时间窗: Baseline and Week 12
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 in Phase 2a
Percentage of Subjects Who Achieved ≥ 2-grade Improvement in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 in Phase 2a
时间窗: Baseline and Week 12
Percentage of subjects who achieved ≥ 2-grade improvement in the investigator global assessment of acne (IGA) from baseline to Week 12 in Phase 2a Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions 1. - Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion 2. - Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3. - Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion 4. - Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 in Phase 2a
时间窗: Baseline and Week 12
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 in Phase 2a
次要结局
未报告次要终点