A Randomised, Double-blinded, Pilot Study Investigating the Safety and Efficacy of Topical P-menthane-3,8-diol Oil Extract in the Treatment of Childhood Impetigo.
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in severity score of impetigo
研究概览
简要总结
This study aims to investigate the efficacy and safety of topical p-menthane-3,8-diol (PMD)-rich Corymbia Citriodora oil (Citriodiol®) in children with impetigo. Citriodiol® is already known to be effective as an insect repellent and is safe in its topical application. The investigators have also found in our laboratory that it is bactericidal against Staphylococcus aureus, the bacteria responsible for causing impetigo. Parents are always searching for a natural alternative to antibiotics (the current gold standard treatment for impetigo), and the investigators believe Citriodiol® could provide this possible alternative.
详细描述
The extract of lemon eucalyptus, a common plant, has since the 1970s been used in commercial insect repellent products. Recently, it has been shown that lemon eucalyptus has potent anti-bacterial and anti-fungal effects that should assist in the treatment of inflammatory conditions such as impetigo. Our aim is to investigate this further by investigating the safety and efficacy of this product in the treatment of Impetigo.
A randomised, double-blinded, three-armed pilot study, involving a total of 30 patients will be recruited from the dermatology outpatient department clinic at Royal North Shore hospital for this study. These patients will be between the ages of 12 months and 12 years with a clinical diagnosis of Impetigo.
The three treatment groups will include a 2% or 5% topical p-menthane-3,8-diol (extracted from lemon eucalyptus) and a topical Mupirocin arm, which will be applied topically twice a day till resolution of symptoms. Follow-up will occur weekly until resolution of symptoms, which is expected within 2 weeks. Photographs, disease severity assessment and lesional swabs for culture will be taken at recruitment and as progress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 12 months and 12 years
- •dermatologist-confirmed impetigo
- •written informed consent provided by parents
排除标准
- •impetigo requiring oral/systemic therapy
- •diagnosis of another form of staphylococcal or streptococcal disease (eg, cellulitis, erysipelas, abscess)
- •serious local infection (eg, cellulitis, abscess, wound infection) or systemic infection
- •oral or topical antibiotics
- •known allergy to topical insect repellents
- •patients receiving systemic corticosteroids, immunosuppressive agents, radiation therapy, chemotherapy within 1 month prior to entry into study
- •history of any clinically significant or poorly controlled cardiac, haematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, psychiatric, and/or other major disease as determined by the investigator
- •current enrollment in any other trial of an investigational drug within 30 days prior to study drug administration
- •other unspecified reasons, in the opinion of the investigator that makes the patient unsuitable for enrollment.
研究组 & 干预措施
2% PMDO
干预措施: p-menthane-3,8-diol oil (Drug)
5% PMDO
干预措施: p-menthane-3,8-diol oil (Drug)
Mupirocin
干预措施: p-menthane-3,8-diol oil (Drug)
结局指标
主要结局
Improvement in severity score of impetigo
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
Shreya Dixit
Dermatology Research Fellow
Royal North Shore Hospital