NCT04155203已完成3 期
Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo's Mupirocin Cream to A Reference Manufacturer's Mupirocin Cream and to Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected Traumatic Skin Lesions
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Padagis LLC
- 入组人数
- 657
- 试验地点
- 1
- 主要终点
- Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms)
研究概览
简要总结
To compare the safety and efficacy of Perrigo's product to an FDA approved product, and to Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected Traumatic Skin Lesions
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 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or non-pregnant females aged 18 months or older.
- •Must have a secondarily infected traumatic skin lesion such as a laceration, sutured wound, or abrasion.
- •Must have a positive baseline culture for S. aureus and/or S. pyogenes from a sample taken from the secondarily infected traumatic skin lesion.
- •Must have a positive Gram stain or Wright stain for confirmation of white blood cells in the pus/exudate from the secondarily infected traumatic skin lesion.
- •Must have a Skin Infection Rating Scale (SIRS) total score for the secondarily infected traumatic skin lesion of at least 8 at baseline.
- •Must be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, and be able to complete the study.
- •Must be in general good health and free from any clinically significant disease, other than secondarily infected traumatic skin lesion(s), that might interfere with the study evaluations.
排除标准
- •Subjects who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation.
- •Presence of any dermatological disorder that may interfere with evaluation of the subject's secondarily infected traumatic skin lesion(s).
- •Presence of bacterial skin infection that, because of depth or severity, could not be appropriately treated with a topical antibiotic.
- •Presence of secondarily infected bite or puncture wound.
- •Presence of systemic signs or symptoms of infection (fever defined as an oral temperature greater than 101°F or 38.3°C).
- •Requirement for surgical intervention for treatment of the infection prior to study entry.
- •Presence of cutaneous herpes simplex infections.
- •Use of any topical corticosteroid, topical antibiotic, or topical antifungal, on the secondarily infected target lesion, within 48 hours prior to Visit 1/Day
- •Use of systemic antibiotics or systemic corticosteroids within 7 days of Visit 1/Day
- •Primary or secondary immunodeficiency.
- •Diagnosed Diabetes Mellitus (controlled or uncontrolled).
- •Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments.
- •History of hypersensitivity or allergy to mupirocin and/or any ingredient in the study medication.
- •Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
- •Subjects who, in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.
研究组 & 干预措施
Reference Active
Active Comparator
干预措施: Mupirocin Calcium (Drug)
Vehicle control
Placebo Comparator
干预措施: Vehicle (Drug)
Perrigo active
Experimental
干预措施: Mupirocin Calcium (Drug)
结局指标
主要结局
Proportion of Subjects in Each Treatment Group With Clinical Cure (Defined as a Skin Infection Rating Scale (SIRS) Score of 0 for All Signs and Symptoms)
时间窗: 18 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the FaceAcne VulgarisNCT03393494Padagis LLC825
已完成
3 期
To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both EyesGlaucoma, Open-AngleOcular HypertensionNCT04024072Padagis LLC495
已完成
3 期
To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both EyesGlaucoma, Open-AngleOcular HypertensionNCT04944290Padagis LLC447
已完成
3 期
Comparative Safety and Efficacy of Two Treatments in the Treatment of Vulvar and Vaginal AtrophyAtrophyNCT02770365Padagis LLC695
已完成
3 期
Comparative Safety and Efficacy of Two Treatments in the Treatment of Acne VulgarisAcneNCT02515305Padagis LLC890