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Citriodiol® and Impetigo

Primary Purpose

Impetigo

Status

Unknown status

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

p-menthane-3,8-diol oil

About this trial

This is an interventional treatment trial for Impetigo focused on measuring p-menthane-3,8-diol oil extract, topical therapy

Eligibility Criteria

12 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Royal North Shore Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

2% PMDO

5% PMDO

Mupirocin

Arm Description

Outcomes

Primary Outcome Measures

Improvement in severity score of impetigo

Secondary Outcome Measures

Full Information

NCT ID

NCT01611909

First Posted

May 29, 2012

Last Updated

June 18, 2012

Sponsor

Royal North Shore Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01611909

Brief Title

Citriodiol® and Impetigo

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 Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

July 2012 (undefined)

Primary Completion Date

January 2013 (Anticipated)

Study Completion Date

March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Royal North Shore Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impetigo

Keywords

p-menthane-3,8-diol oil extract, topical therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

2% PMDO

Arm Type

Experimental

Arm Title

5% PMDO

Arm Type

Experimental

Arm Title

Mupirocin

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

p-menthane-3,8-diol oil

Intervention Description

Apply topically to affected area twice daily

Primary Outcome Measure Information:

Title

Improvement in severity score of impetigo

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shreya Dixit, B Med Sci, MBBS (Hons)

Phone

(02) 9926 7111

Ext

42218

rnsdermresearch@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Gayle Fischer, MBBS (Hons), FACD

gayle.fischer@sydney.edu.au

Facility Information:

Facility Name

Royal North Shore Hospital

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shreya Dixit, B Med Sci, MBBS (Hons)

Phone

(02) 9926 7111

Ext

42218

rnsdermresearch@gmail.com

First Name & Middle Initial & Last Name & Degree

Shreya Dixit, B Med Sci, MBBS (Hons)

12. IPD Sharing Statement

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Citriodiol® and Impetigo

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