NCT03075891已完成4 期
Efficacy Comparison of Ivermectin 1% Topical Cream Associated With Doxycycline 40 mg Modified Release (MR) Capsules Versus Ivermectin 1% Topical Cream Associated With Placebo in the Treatment of Severe Rosacea
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 273
- 试验地点
- 4
- 主要终点
- Percent Change From Baseline in Inflammatory Lesion Count at Week 12
研究概览
简要总结
The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical cream associated with Placebo in the treatment of severe Rosacea.
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
- Double (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 or female subject age ≥ 18 years or older;
- •Subject with a minimum of 20 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face at Baseline visit;
- •Subject with severe rosacea with papulopustular lesions (according to the Investigator's Global Assessment (IGA) score rated 4);
- •Female subjects of childbearing potential with a negative urine pregnancy test (UPT);
- •Female subjects of childbearing potential must practice a highly effective method of contraception during the study.
排除标准
- •Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea;
- •Subjects with more than 2 nodules of rosacea on the face;
- •Subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject;
- •Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients doxycycline and ivermectin.
研究组 & 干预措施
Ivermectin 1% cream + Doxycycline 40 mg MR capsules
Experimental
干预措施: Ivermectin 1% cream (Drug)
Ivermectin 1% cream + Doxycycline 40 mg MR capsules
Experimental
干预措施: Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules (Drug)
Ivermectin 1% cream + Oral placebo capsules
Placebo Comparator
干预措施: Ivermectin 1% cream (Drug)
Ivermectin 1% cream + Oral placebo capsules
Placebo Comparator
干预措施: Oral placebo capsules (Other)
结局指标
主要结局
Percent Change From Baseline in Inflammatory Lesion Count at Week 12
时间窗: Baseline, Week 12
Percent change from baseline in inflammatory lesion count at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (that is \[i.e.\] papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter (cm) in diameter; and Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.
次要结局
- Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8(Baseline, Weeks 4 and 8)
- Percentage of Participants With Clear Inflammatory Lesions at Week 12(Week 12)
- Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12(Weeks 4, 8 and 12)
- Clinician's Erythema Assessment (CEA) Total Score at Weeks 4, 8 and 12(Weeks 4, 8 and 12)
- Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12(Weeks 4, 8 and 12)
- Investigator's Global Assessment (IGA) Total Score at Weeks 4, 8 and 12(Weeks 4, 8 and 12)
- Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12(Weeks 4, 8 and 12)
- Stinging/Burning Severity Score at Weeks 4, 8 and 12(Weeks 4, 8 and 12)
- Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12(Weeks 4, 8 and 12)
- Global Improvement Total Score at Week 12 (Last Visit/Early Termination)(Week 12 (last visit/early termination))
- Percentage of Participants in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination)(Week 12 (last visit/early termination))
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From the signing of the informed consent form (ICF) up to Week 12)
- Dermatology Life Quality Index (DLQI) Questionnaire Total Score at Week 12 (Last Visit/Early Termination Visit)(Week 12 (last visit/early termination))
- Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category(Baseline, Week 12 (last visit/early termination))
- Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire (How Much Rosacea Affect Productivity at Work, How Much Rosacea Affect Daily Activity) at Week 12 (Last Visit/Early Termination Visit)(Week 12 (Last visit/Early termination visit))
- Percent Change From Baseline in Dermatology Life Quality Index Questionnaire Total Score at Week 12 (Last Visit/Early Termination)(Baseline, Week 12 (last visit/early termination))
- EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire at Week 12 (Last Visit/Early Termination Visit)(Week 12/Last visit or early termination visit)
- Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination)(Baseline, Week 12 (last visit/early termination))
- Percentage of Participants Reported Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire for Currently Employed Question at Week 12 (Last Visit/Early Termination Visit)(Week 12 (Last visit/early termination visit))
- Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire - Hours Missed at Work, Impact to Productivity at Work and Daily Activities at Week 12(Week 12 (Last visit/Early termination visit))
- Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A(Week 12 (Last visit/early termination visit))
- Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part D(Week 12 (Last visit/early termination visit))
- Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B(Week 12 (Last visit/early termination visit))
- Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part C(Week 12 (Last visit or early termination visit))
研究者
研究点 (4)
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