NCT00403949已完成2 期
A 6-week, Vehicle-controlled, Randomized, Double-blind, Parallel-group Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Perioral Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 48
- 主要终点
- The sum score derived from the most important signs and symptoms of perioral dermatitis
研究概览
简要总结
The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.
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
- •Clinical diagnosis of mild to moderate perioral dermatitis as diagnosed by the physician
- •Investigator's Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to 4)
- •8 to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles)
排除标准
- •History of atopic dermatitis of the face
- •Granulomatous perioral dermatitis
- •Facial acne, rosacea, facial demodicosis
- •Seborrheic dermatitis of the nasolabial fold, Lupus erythematosus
- •The use of topical or systemic medications that could affect the course of treatment and/or evaluation
- •Severe diseases likely to interfere with the conduct / planned termination of the study (e.g. cancer, cardiac infarct, unstable angina pectoris, uncontrolled diabetes)
- •Use of fluorinated toothpaste
- •Planned exposure to artificial or intensive natural UV light of the test area throughout the course of the study
- •Use / planned use of cosmetic products (e.g. creams, moisturizers, make-up, fatty lipstick) in the test area during the course of the study
- •History of or suspected hypersensitivity to any ingredient of the study drugs
- •Participation in another clinical study 4 weeks prior to and/or during the conduct of this study
研究组 & 干预措施
Azelaic acid 15% Gel
Active Comparator
Azelaic acid 15%
干预措施: Azelaic acid 15% gel (Drug)
Placebo
Placebo Comparator
Non-active base from Azelaic acid 15% gel
干预措施: Non-active base from azelaic acid 15% gel (Drug)
结局指标
主要结局
The sum score derived from the most important signs and symptoms of perioral dermatitis
时间窗: Measurements and observations during the course of the study
次要结局
- Intensity of single signs and symptoms(Measured at scheduled visits during the course of the study)
- Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator(Safety parameters recorded at scheduled visits during the course of the study)
研究者
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