Prospective 2-Year Longitudinal Study to Assess for Miconazole Resistance in Candida Spp. With Repeated Treatment Courses of 0.25% Miconazole Nitrate Ointment in Neonates and Infants up to 1 Year of Age With Recurrent Moderate-Severe Diaper Dermatitis Complicated by Cutaneous Candidiasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Number of Participants With Overall Cure (OC)
研究概览
简要总结
The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate ointment in newborns and infants with a yeast infection in the diaper area causes the yeast to become resistant to the drug.
详细描述
The objective of this study is to investigate the potential for the development of resistance in Candida spp. after repeated treatment courses of 0.25% miconazole nitrate ointment in neonates and infants up to one year of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female neonate or infant up to 1 year of age with Fitzpatrick Skin Type I-VI
- •Clinical evidence of diaper dermatitis and a positive KOH result for pseudohyphae and/or budding yeast at baseline visit
- •Overall Diaper Dermatitis Severity Index score at baseline visit of 4-8 (must include an overall clinical grade of at least 2 for erythema)
- •Wear commercially available diapers day and night for at least 7 days prior to enrollment and during the course of the 2 year study
- •Caretaker must complete informed consent process
排除标准
- •Known sensitivity to any component of the formulation
- •No other skin conditions that may confound the evaluation of the drug efficacy or tolerability
- •Known sensitivity to skin care toiletry products or diapers
- •History of HIV positive
- •Chronic illnesses that require systemic medication that may confound the evaluation of study drug efficacy or tolerability (antibiotic therapy is not included)
- •Treatment with a prescription product for diaper dermatitis or other skin condition 7 days prior to enrollment
研究组 & 干预措施
Miconazole Nitrate
干预措施: 0.25 % Miconazole Nitrate Ointment (Drug)
结局指标
主要结局
Number of Participants With Overall Cure (OC)
时间窗: Test-of-cure visit (Day 14) of initial treatment episode
OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide \[KOH\] and culture results). Participants who had OC were categorized as "Successes"; those without OC were categorized as "Failures." Any discontinued or lost to follow-up participant was also considered a failure.
次要结局
- Number of Participants With Clinical Cure(Test-of-cure visit (Day 14) of initial treatment episode)
- Number of Participants With Mycological Cure(Test-of-cure visit (Day 14) of initial treatment episode)
- Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode(Test-of-cure visit (Day 14) of initial treatment episode)
- Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode(Test-of-cure visit (Day 14) of initial treatment episode)
- Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)(Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months))
- Number of Participants With Clinical Cure of First to Third Recurrent Episodes(Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months))
- Number of Participants With Mycological Cure of First to Third Recurrent Episodes(Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months))