Citriodiol® and Impetigo

Phase 2

• Conditions: Impetigo
• Interventions: Drug: p-menthane-3,8-diol oil

• Registration Number: NCT01611909
• Lead Sponsor: Royal North Shore Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-31
• Status Verified: 2012-06
• Study First Posted: 2012-06-05
• Last Update Submitted: 2012-06-18
• Last Update Posted: 2012-06-20
• Study Start: 2012-07
• Primary Completion: 2013-01
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• age between 12 months and 12 years
• dermatologist-confirmed impetigo
• written informed consent provided by parents

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2% PMDO	p-menthane-3,8-diol oil	-
5% PMDO	p-menthane-3,8-diol oil	-
Mupirocin	p-menthane-3,8-diol oil	-

Primary Outcome Measures

Name	Time	Method
Improvement in severity score of impetigo	2 weeks

Trial Locations

Locations (1)

Royal North Shore Hospital; 🇦🇺 St Leonards, New South Wales, Australia