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Citriodiol® and Impetigo

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):

May 29, 2012
June 5, 2012
June 20, 2012
July 2012
January 2013   (Final data collection date for primary outcome measure)
Improvement in severity score of impetigo [ Time Frame: 2 weeks ]
Same as current
Complete list of historical versions of study NCT01611909 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Impetigo
Drug: p-menthane-3,8-diol oil
Apply topically to affected area twice daily
  • Experimental: 2% PMDO
    Intervention: Drug: p-menthane-3,8-diol oil
  • Experimental: 5% PMDO
    Intervention: Drug: p-menthane-3,8-diol oil
  • Active Comparator: Mupirocin
    Intervention: Drug: p-menthane-3,8-diol oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
March 2013
January 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Months to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01611909
Citriodiol®&Impetigo-001
No
Not Provided
Not Provided
Shreya Dixit, Royal North Shore Hospital
Royal North Shore Hospital
Not Provided
Not Provided
Royal North Shore Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP