A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 744
- 试验地点
- 45
- 主要终点
- Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
研究概览
简要总结
The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent and, for subjects under legal adult age, signed assent
- •Age ≥ 9 years
- •Clinical diagnosis of facial acne vulgaris defined as:
- •At least 20 inflammatory lesions, and
- •At least 20 non-inflammatory lesions, and
- •Investigator Global Assessment of 3 or greater
排除标准
- •Active cystic acne or acne conglobata, acne fulminans, and secondary acne
- •Two or more active nodulocystic lesions on the face
- •Clinically significant abnormal laboratory or ECG result
- •Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline visit
- •Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline
- •Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid within 4 weeks prior to Baseline
- •Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills).
- •Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks prior to Baseline.
- •Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A supplements greater than 10,000 units/day within 6 months prior to Baseline
- •Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks
研究组 & 干预措施
Olumacostat Glasaretil Gel, 5.0%
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
干预措施: Olumacostat Glasaretil Gel, 5.0% (Drug)
Olumacostat Glasaretil Gel, Vehicle
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 (Inflammatory) From Baseline to Week 12
时间窗: Baseline and Week 12
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
时间窗: Baseline and Week 12
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12
时间窗: Baseline and Week 12
Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 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
次要结局
未报告次要终点