Citriodiol® and Impetigo

Impetigo Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01611909
• Other study ID #: Citriodiol®&Impetigo-001
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: May 29, 2012
• Last updated: June 18, 2012
• Start date: July 2012
• Est. completion date: March 2013

Study information

• Verified date: June 2012
• Source: Royal North Shore Hospital
• Contact: Shreya Dixit, B Med Sci, MBBS (Hons)
• Phone: (02) 9926 7111
• Email: rnsdermresearch[@]gmail.com
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impetigo

Intervention

Drug:
• p-menthane-3,8-diol oil
Apply topically to affected area twice daily

Locations

Country	Name	City	State
Australia	Royal North Shore Hospital	St Leonards	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Royal North Shore Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in severity score of impetigo		2 weeks	No