Use of Altabax Ointment (Retapamulin 1%) BID for 7 Days in Treatment of Secondary Infection With Staphylococcus Aureus (MRSA and MSSA) and Streptococcus Pyogenes in Atopic Dermatitis Patients - Open Label Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Bacteriological Culture
研究概览
简要总结
Skin infections may complicate the treatment of atopic dermatitis.The use of topical ointments has become very important to avoid the use of oral antibiotics. There is little supporting literature regarding the use of topical antibiotics in secondarily infected atopic dermatitis.
This study will investigate the safety and effectiveness of Altabax ointment use in treating secondarily infected atopic dermatitis caused by Staphylococcus aureus and Streptococcus pyogenes.
详细描述
Atopic dermatitis patients are commonly secondarily infected with Staphylococcus aureus and/or Streptococcus pyogenes, more recently with Methicillin-resistant Staphylococcus aureus (MRSA), due to impaired barrier function. As cutaneous infections such as MRSA and others may complicate the treatment of atopic dermatitis, the use of topical antibiotics have become very important to avoid oral antibiotics and their side effects, especially in the pediatric population.
The current study will investigate the safety and efficacy of Altabax ointment use for treatment of secondarily infected lesions caused by Staphylococcus aureus and Streptococcus pyogenes in both the pediatric and adult populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception.
- •Secondary infection of atopic dermatitis with S.aureus or S.pyogenes as the probable causative agent.
- •An infected area less than or equal to 100 centimeters squared for subjects 18 years of age or older, or, 2% body surface area for subjects under 18 years of age.
- •Skin Infection Rating Scale score greater than or equal to
- •Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance Portability and Accountability Authorization Forms. Subjects under the legal age of consent must also have the written informed consent of parent or legal guardian.
排除标准
- •Female subjects who are pregnant, trying to get pregnant, breast feeding or who are of childbearing potential and not practicing reliable birth control.
- •Allergic to any component of the test medication.
- •Clinical diagnosis of impetigo, folliculitis or minor soft tissue infection.
- •Use of topical antibacterial medication to the study treatment area within 1 day of Visit
- •Signs of systemic infection or evidence of abcess or cellulitis at the site to be treated.
- •Medical condition that,in the opinion of the investigator, contraindicates the subject's participation in the clinical study.
- •Recent alcohol or drug abuse is evident.
- •History of poor cooperation, non-compliance with medical treatment or unreliability.
- •Participation in an investigational drug study within 30 days of Baseline Visit.
结局指标
主要结局
Bacteriological Culture
时间窗: Day 1 and Day 7
All participants were cultured for S.aureus (MRSA), S.aureus (MSSA) and S. pyogenes at Baseline. If positive at Baseline then they were cultured again at Day 7.
次要结局
- Investigator Assessment of Clinical Cure(Day 7)
- Local Tolerability(Day 7)
- Skin Infection Rating Scale (SIRS)(Day 1 and Day 7)
研究者
Leon Kircik, M.D.
Principal Investigator
Derm Research, PLLC