Citriodiol® and Impetigo
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Impetigo |
Drug: p-menthane-3,8-diol oil |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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. |
- Improvement in severity score of impetigo [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 2% PMDO |
Drug: p-menthane-3,8-diol oil
Apply topically to affected area twice daily
|
| Experimental: 5% PMDO |
Drug: p-menthane-3,8-diol oil
Apply topically to affected area twice daily
|
| Active Comparator: Mupirocin |
Drug: p-menthane-3,8-diol oil
Apply topically to affected area twice daily
|
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.
Eligibility| Ages Eligible for Study: | 12 Months to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Shreya Dixit, B Med Sci, MBBS (Hons) | (02) 9926 7111 ext 42218 | rnsdermresearch@gmail.com |
| Contact: Gayle Fischer, MBBS (Hons), FACD | gayle.fischer@sydney.edu.au |
| Australia, New South Wales | |
| Royal North Shore Hospital | Not yet recruiting |
| St Leonards, New South Wales, Australia, 2065 | |
| Contact: Shreya Dixit, B Med Sci, MBBS (Hons) (02) 9926 7111 ext 42218 rnsdermresearch@gmail.com | |
| Sub-Investigator: Shreya Dixit, B Med Sci, MBBS (Hons) | |
More Information
No publications provided
| Responsible Party: | Shreya Dixit, Dermatology Research Fellow, Royal North Shore Hospital |
| ClinicalTrials.gov Identifier: | NCT01611909 History of Changes |
| Other Study ID Numbers: | Citriodiol®&Impetigo-001 |
| Study First Received: | May 29, 2012 |
| Last Updated: | June 18, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Human Research Ethics Committee |
Keywords provided by Royal North Shore Hospital:
|
p-menthane-3,8-diol oil extract topical therapy |
Additional relevant MeSH terms:
|
Staphylococcal Skin Infections Skin Diseases, Infectious Impetigo Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Streptococcal Infections Skin Diseases, Bacterial |
Infection Skin Diseases Menthol Antipruritics Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013