Citriodiol® and Impetigo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01611909
Recruitment Status : Unknown
Verified June 2012 by Shreya Dixit, Royal North Shore Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 5, 2012
Last Update Posted : June 20, 2012
Information provided by (Responsible Party):
Shreya Dixit, 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.

Condition or disease Intervention/treatment Phase
Impetigo Drug: p-menthane-3,8-diol oil Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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.
Study Start Date : July 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Impetigo

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Improvement in severity score of impetigo [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01611909

Contact: Shreya Dixit, B Med Sci, MBBS (Hons) (02) 9926 7111 ext 42218
Contact: Gayle Fischer, MBBS (Hons), FACD

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   
Sub-Investigator: Shreya Dixit, B Med Sci, MBBS (Hons)         
Sponsors and Collaborators
Royal North Shore Hospital

Responsible Party: Shreya Dixit, Dermatology Research Fellow, Royal North Shore Hospital Identifier: NCT01611909     History of Changes
Other Study ID Numbers: Citriodiol®&Impetigo-001
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: June 2012

Keywords provided by Shreya Dixit, Royal North Shore Hospital:
p-menthane-3,8-diol oil extract
topical therapy

Additional relevant MeSH terms:
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Skin Diseases
Respiratory System Agents
Dermatologic Agents