NCT01943136Unknown1 期
The Efficacy and Safety of Topical Papaya (Carica Papaya) Leaf Extract 1% Ointment Versus Mupirocin 2% Ointment in the Treatment of Limited Impetigo: a Randomized, Double-blind, Controlled Clinical Trial
Philippine Dermatological Society1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Clinical clearance after 1 week of treatment
研究概览
简要总结
This study will be an investigator-blinded, patient-blinded, assessor-blinded, parallel-group, randomized clinical trial. It aims to evaluate the efficacy of one-week twice-daily application of topical papaya leaf extract ointment compared to mupirocin ointment in achieving clinical cure among patients with impetigo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Filipino patients aged 1 year and above with primary impetigo, limited to less than or equal to 1% BSA, and involving only one body area
排除标准
- •Extensive impetigo (>1% BSA), affecting more than one body area
- •Systemic involvement (lymphadenopathy, fever, sepsis)
- •Chronic comorbidities like diabetes mellitus, malignancy, chronic venous insufficiency
- •Concurrent immunosuppressive therapy
- •Patients ≤ 1 year
- •Pregnant & lactating patients
研究组 & 干预措施
papaya 1% extract ointment
Experimental
papaya 1% extract ointment twice a day for 1 week
干预措施: papaya 1% extract ointment (Drug)
mupirocin 2% ointment
Active Comparator
mupirocin 2% ointment twice a day for 1 week
干预措施: mupirocin 2% ointment (Drug)
结局指标
主要结局
Clinical clearance after 1 week of treatment
时间窗: 1 week
次要结局
- time to clinical clearance(1 week)
- score in the 6-point grading system(1 week)
- change in size of lesion compared to baseline(1 week)
- presence or absence of recurrence on any part of the body 2 weeks after starting treatment(1 week)
- presence or absence of adverse events during treatment(1 week)
研究者
Pearl Weena Marie Sabido
Dr.
Philippine Dermatological Society
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital WartsAnogenital WartsCondylomata AcuminataHuman Papillomavirus InfectionNCT01532102Anaconda Pharma24
招募中
3 期
A Randomized Control Trial Phase (IIIa) Unicentric, Placebo Controlled, Double-Blinded Efficacy and Safety of Topical Alendronic Acid on Alveolar Bone Remodeling After Tooth ExtractionBone Loss, AlveolarNCT05602493Xeolas Pharmaceuticals Limited60
已完成
3 期
Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain SymptomsPainNCT02497066Walter Reed National Military Medical Center399
已完成
1 期
Topical 3% Amphotericin B Cream for the Treatment of Cutaneous Leishmaniasis in ColombiaCutaneous LeishmaniasisNCT01845727Drugs for Neglected Diseases80
已完成
3 期
Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big ToenailOnychomycosisNCT00443820Novartis Pharmaceuticals526