Citriodiol® and Impetigo

NCT01611909 | Unknown Phase 2

• 1 other identifier: Citriodiol®&Impetigo-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Impetigo

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Improvement in severity score of impetigo

  2 weeks

Study Arms (3)

2% PMDO

EXPERIMENTAL

Drug: p-menthane-3,8-diol oil

5% PMDO

EXPERIMENTAL

Drug: p-menthane-3,8-diol oil

Mupirocin

ACTIVE COMPARATOR

Drug: p-menthane-3,8-diol oil

Interventions

p-menthane-3,8-diol oil DRUG

Apply topically to affected area twice daily

2% PMDO; 5% PMDO; Mupirocin

Eligibility Criteria

• Age: 12 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between 12 months and 12 years
• dermatologist-confirmed impetigo
• written informed consent provided by parents

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal North Shore Hospital: lead

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

MeSH Terms

Conditions

Impetigo

Interventions

terpin

Condition Hierarchy (Ancestors)

Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Streptococcal Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Shreya Dixit, B Med Sci, MBBS (Hons)

CONTACT

(02) 9926 7111; rnsdermresearch@gmail.com

Gayle Fischer, MBBS (Hons), FACD

CONTACT

gayle.fischer@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology Research Fellow

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 5, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

AU (1)