A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study to Assess the Efficacy, Safety 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
- 2 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 14
- 主要终点
- Total Inflammatory Lesion Count Reduction
研究概览
简要总结
Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline.
详细描述
Two hundred (200) male and female subjects with papulopustular rosacea will be enrolled to get 176 completed subjects (forty-four (44) completers each in groups 1 to 4).
After assessing eligibility during an up to 28 days screening period, 200 subjects will be enrolled in the study (fifty subjects each in groups 1 to 4). Subject visits are scheduled at Screening, Baseline (Day 1), and Weeks 4, 8, 12 and 16.
Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline. Additionally, high sensitivity C-reactive protein (hs-CRP) in the blood will be assessed at Baseline, and at Week 16 to explore any impact of the treatment on the inflammatory pathology.
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)
盲法说明
Each subject will be allocated to one of the following treatment groups, receiving 1 capsule once daily in the morning for 16 weeks:
- DFD-29 Extended Release Capsules (40 mg)
- DFD-29 Extended Release Capsules (20 mg)
- Doxycycline Modified Release Hard Capsules (40 mg)
- Placebo Capsules
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
- •Subjects must be able to understand the requirements of the study and be willing to give written informed consent.
- •Male and female subjects aged 18 years and above.
- •Subjects, any gender or ethnicity (and of Fitzpatrick skin type I - III), must be in good general health as determined by the Investigator.
- •Subjects must have a clinical diagnosis of papulopustular rosacea, IGA grade 2 -
- •Subjects must have 10 - 40 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face.
- •Subjects must have not more than 2 nodules.
- •Subjects with moderate to severe erythema with a total score of 5 - 20 on the CEA scale.
- •Females must have a negative urine pregnancy test at the screening and baseline visit.
- •Females must either be postmenopausal with no menses for at least 12 months or surgically sterile (hysterectomy or tubal ligation) or agree to use a highly effective method of contraception with a pearl index of <1% up to 1 month after last dose.
- •Subjects must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).
排除标准
- •Females who are pregnant or nursing or planning to become pregnant during the study.
- •Male whose female partner is planning to conceive a child.
- •Subjects who have been treated for rosacea within the 30 days prior to the Baseline Visit (e.g. metronidazole, azelaic acid, doxycycline or brimonidine).
- •Subjects who have been treated with systemic retinoids within 6 months prior to the Baseline visit.
- •Subjects who have participated in a trial involving any investigational product in the 90 days prior to the Baseline Visit.
- •Subjects with any disease or medical condition that would interfere with the study outcome or place the subject at undue risk.
- •Subjects who use or have used systemic steroids within the 30 days prior to the Baseline Visit or any other immunosuppressive medication.
- •Subjects who are on anti-coagulants or those who are likely to require anti-coagulants during the study period.
- •History of drug or alcohol abuse in the last year.
研究组 & 干预措施
DFD-29 Extended Release Capsules (40 mg)
DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.
干预措施: DFD-29 Extended Release Capsules (40 mg) (Drug)
DFD-29 Extended Release Capsules (20 mg)
DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.
干预措施: DFD-29 Extended Release Capsules (20 mg) (Drug)
Oraycea® (doxycycline) Capsules
Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.
干预措施: Oraycea® (doxycycline) Capsules (Drug)
Placebo Capsules
Placebo Capsules once per day for 16 weeks.
干预措施: Placebo Capsules (Drug)
结局指标
主要结局
Total Inflammatory Lesion Count Reduction
时间窗: 16 Weeks
The total inflammatory lesion count is carried out by visual inspection by the Investigator at every study visit from Screening up to Week 16 (or at early termination). Inflammatory lesions will be recorded on a diagram of a human face, divided in 4 quadrants.
Investigator Global Assessment (IGA) 0=Clear, 1=Near Clear, 2=Mild, 3=Moderate, 4=Severe
时间窗: 16 weeks
Proportion of subjects with Investigator Global Assessment (IGA) 'treatment success' - Grade 0 or 1 at the end of study with at least 2 grade reduction from Baseline to Week 16.
次要结局
- Median Change in RosaQoL (Rosacea Quality of Life) Score From Baseline to Week 16(Median change in the score from Baseline to Week 16)