NCT01611909

Citriodiol® and Impetigo

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.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Royal North Shore Hospital · Academic / Other
• Sex: All
• Age: 12 Months – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Impetigo

Interventions

Type	Name	Description
DRUG	p-menthane-3,8-diol oil	Apply topically to affected area twice daily

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-01-01
• Completion: 2013-03-01
• First posted: 2012-06-05
• Last updated: 2012-06-20

Locations

1 site across 1 country: Australia