Trial record 12 of 173 for:    Open Studies | "Skin Diseases, Infectious"

Citriodiol® and Impetigo

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Royal North Shore Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Shreya Dixit, Royal North Shore Hospital
ClinicalTrials.gov Identifier:
NCT01611909
First received: May 29, 2012
Last updated: June 18, 2012
Last verified: June 2012
  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.

Resource links provided by NLM:


Further study details as provided by Royal North Shore Hospital:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611909

Contacts
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

Locations
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)         
Sponsors and Collaborators
Royal North Shore Hospital
  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
Terpin
Menthol
Expectorants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on September 14, 2014