Efficacy of 45mg Oral Minocycline (Solodyn) and 45mg Oral Minocycline (Solodyn) Plus 15% Azelaic Acid (Finacea) in the Treatment of Acne Rosacea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Efficacy analysis of the 12-week reduction in total lesion count
研究概览
简要总结
Rosacea is one of the most commonly occurring dermatoses treated by dermatologist today. Rosacea is an inflammatory condition of the skin presenting as flushing and or blushing along with redness, swelling, telangiectasia, and acne lesions. Minocycline has shown beneficial in the treatment of inflammatory acne lesions in patients with rosacea. This study is to evaluate the efficacy and tolerability of minocycline (Solodyn) alone versus minocycline (Solodyn) in combination with azelaic acid 15%(Finacea) in the treatment of rosacea.
详细描述
This is a multicenter, randomized, outpatient, Investigator-blind study of minocycline 45 mg and minocycline 45 mg plus 15% azelaic acid for the treatment of rosacea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (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
- 是
入选标准
- •age 18 or older with clinical diagnosis of rosacea
- •must have 10-40 facial inflammatory lesions and less than 2 nodules
- •women of child bearing potential must be non lactating
- •must have negative urine pregnancy test
- •must use effective form of birth control
排除标准
- •The use of systemic antibiotics within 30 days of study start
- •the use of topical medications within 14 - 30 days of study start depending on type of topical medication
- •Patients with known sensitivity to tetracyclines
- •Patients who have had gastric bypass surgery or are considered achlorhydric
- •Patients taking drugs known as photosensitizers
研究组 & 干预措施
minocycline, azelaic acid
minocycline vs minocycline in comination with 15% azelaic acid for treatment of rosacea
干预措施: Minocycline 45 MG (Drug)
minocycline, azelaic acid
minocycline vs minocycline in comination with 15% azelaic acid for treatment of rosacea
干预措施: Azelaic acid (Drug)
azelaic acid
45 mg oral minocycline vs 45 mg oral minocycline plus 15% azelaic acid in the treatment of facial rosacea
干预措施: Minocycline 45 MG (Drug)
azelaic acid
45 mg oral minocycline vs 45 mg oral minocycline plus 15% azelaic acid in the treatment of facial rosacea
干预措施: Azelaic acid (Drug)
结局指标
主要结局
Efficacy analysis of the 12-week reduction in total lesion count
时间窗: 12 weeks
The goal of analysis is to assess evidence of overall effect of 45mg minocycline and overall effect of 45 mg minocycline plus 15% azelaic acid in therapy of patients with acne rosacea.
次要结局
- Efficacy analysis of the12 week reduction in IGA (Investigators Global Assessment) per treatment group(12 Weeks)
- Efficacy analysis of the 12-week reduction in CEA (Clinical Erythema Assessment) per treatment group(12 Weeks)