NCT00417937已完成4 期
A Multicenter, Double-Blind Clinical Trial to Assess the Efficacy and Tolerability of Topical Azelaic Acid 15% Gel Once Daily Compared to Topical Azelaic Acid 15% gelTwice Daily in Subjects With Papulopustular 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
- LEO Pharma
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Investigator's global assessment scored on a seven point scale
研究概览
简要总结
To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.
详细描述
To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular 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 (Participant, Investigator)
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
- •Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or pustules
排除标准
- •Mild or severe rosacea
- •Rosacea with marked ocular manifestations
- •Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation of the study course
- •Wash out period required for patients treated prior to study with topical retinoids, oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical imidazole, laser surgery for telangiectasia
- •History of hypersensitivity to propylene glycol
研究组 & 干预措施
1
Active Comparator
Azelaic acid 15 % gel once daily
干预措施: azelaic acid 15% gel (Drug)
2
Active Comparator
Azelaic acid 15 gel twice daily
干预措施: azelaic acid 15% gel (Drug)
结局指标
主要结局
Investigator's global assessment scored on a seven point scale
时间窗: Measurements made during the course of treatment
次要结局
- Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy(Parameters measured during the course of treatment)
研究者
研究点 (1)
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