A Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo Controlled Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 24
- 主要终点
- Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo.
研究概览
简要总结
This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks. Of the 320 subjects, approximately 160 subjects are planned to be enrolled at 15 sites in the US, while the remaining subjects are to be enrolled at 14 sites in the EU.
详细描述
This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks.
Subject visits are scheduled at Screening, Baseline (Day 1), and Weeks 2, 4, 8, 12, and 16. Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment modified scale without erythema (IGA), Clinician's Erythema Assessment (CEA), and total inflammatory lesion count at Weeks 2, 4, 8, 12, and 16 compared to Baseline.
Laboratory assessments of blood (hematology and biochemistry) and urine (routine tests) will be conducted at Screening and Week 16 (end of study [EOS] or early termination) to assess for any changes in the safety parameters. Other safety assessments include vital signs, physical examination, urine pregnancy tests (for females of childbearing potential), and collection of AE data.
The impact of the treatment on the quality of life (QoL) of the subjects will be assessed using the rosacea-specific tool RosaQoL in addition to the Dermatology Life Quality Index (DLQI) at Baseline and Weeks 2, 4, 8, 12, and 16.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 18 years and above.
- •Subjects must be in good general health as determined by the investigator and supported by the medical history.
- •Subjects must have a clinical diagnosis of papulopustular rosacea with IGA grade 3 (moderate) or IGA grade 4 (severe) at Baseline.
- •Subjects must have 15 to 60 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face at Baseline.
- •Subjects must have not more than 2 nodules or cysts at Baseline.
排除标准
- •Female subjects who are pregnant or nursing or planning to become pregnant during the study.
- •Male subjects whose female partner is planning to conceive a child.
- •Clinically significant abnormal laboratory test results that, in the opinion of the investigator, would compromise the subject's safety or ability to participate in the trial.
- •History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.
- •History of lupus-like syndrome, autoimmune hepatitis, vasculitis, or serum sickness.
- •Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
研究组 & 干预措施
DFD-29
DFD-29 (40 mg) extended release capsules
干预措施: DFD-29 (Drug)
Doxycycline 40 mg
Doxycycline 40 mg modified release capsules
干预措施: Doxycycline (Drug)
Placebo
Placebo capsules matching DFD-29
干预措施: Placebo (Drug)
结局指标
主要结局
Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo.
时间窗: Baseline to Week 16
Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo. The modified IGA scale is a 5-point scale from Grade 0 to Grade 4, wherein Grade 0 is Clear, Grade 1 is Near Clear, Grade 2 is Mild, Grade 3 is Moderate and Grade 4 is Severe Rosacea. A lowering of the score with treatment indicates an improvement in the disease condition and a beneficial outcome.
Change in Total Inflammatory Lesion Count Compared to Placebo.
时间窗: Baseline to Week 16.
Total inflammatory lesion count (sum of papules, pustules, and nodules) change from Baseline to Week 16, in the DFD-29 group compared to Placebo.
次要结局
- IGA Treatment Success Compared to Doxycycline.(Baseline to Week 16.)
- Change in Total Inflammatory Lesion Count Compared to Doxycycline.(Baseline to Week 16.)
- Clinician's Erythema Assessment (CEA) Change Compared to Placebo.(Baseline to Week 16.)