Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12609000231246
Ethics application status
Approved
Date submitted
9/10/2008
Date registered
8/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
The use of honey in the treatment of molluscum contagiosum in children
Query!
Scientific title
The effect of topical honey application on molluscum contagiosum skin lesions
Query!
Secondary ID [1]
273402
0
Not applicable
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
molluscum contagiosum
3810
0
Query!
Condition category
Condition code
Skin
3992
3992
0
0
Query!
Dermatological conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Manuka honey applied topically to the skin lesions and covered with a transparent adhesive dressing, changed every two days, for a total duration of 4 weeks
Query!
Intervention code [1]
3530
0
Treatment: Other
Query!
Comparator / control treatment
There is no control group, a baseline comparison will be made.
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
4896
0
Assessment of response to treatment based on de-identified photographs of the pre-selected target treatment area by a blinded reviewer - the response will be graded as "complete response", "partial response" or "no response".
Query!
Assessment method [1]
4896
0
Query!
Timepoint [1]
4896
0
After 2 and 4 weeks of treatment
Query!
Secondary outcome [1]
8945
0
Parent/caregiver assessment of response after treatment.
Query!
Assessment method [1]
8945
0
Query!
Timepoint [1]
8945
0
4 weeks
Query!
Secondary outcome [2]
8946
0
Parent/caregiver assessment of treatment acceptability after treatment.
Query!
Assessment method [2]
8946
0
Query!
Timepoint [2]
8946
0
4 weeks
Query!
Secondary outcome [3]
8947
0
Assessment of compliance with dressing changes.
Query!
Assessment method [3]
8947
0
Query!
Timepoint [3]
8947
0
At 2 and 4 weeks.
Query!
Eligibility
Key inclusion criteria
1. 3-16 years old
2. Presenting to the General practitioner with classic uncomplicated molluscum contagiosum skin lesions of mild-moderate severity
3. Parent/caregiver agrees to be compliant with application of the honey dressings
Query!
Minimum age
3
Years
Query!
Query!
Maximum age
16
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Study doctor decision that the patient is not suitable for the study
2. Immunocompromised child
3. Presence of co-existing eczema or other skin disorders
4. Children with known food allergies or history of allergy to bees or honey products
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
27/04/2009
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
15
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
1258
0
New Zealand
Query!
State/province [1]
1258
0
Query!
Funding & Sponsors
Funding source category [1]
3992
0
Other
Query!
Name [1]
3992
0
Mr Laurence Grieg of Grow Wellington
Query!
Address [1]
3992
0
Level 4,
50 Manners Street
Wellington 6011
Query!
Country [1]
3992
0
New Zealand
Query!
Primary sponsor type
Charities/Societies/Foundations
Query!
Name
Medical Research Institute of New Zealand
Query!
Address
Level 7 CSB Building
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
3582
0
Individual
Query!
Name [1]
3582
0
Shaun Holt
Query!
Address [1]
3582
0
Clinicanz
Level 2 Jesmond House
405 Cameron Road
Tauranga 3140
Query!
Country [1]
3582
0
New Zealand
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
6067
0
Query!
Ethics committee address [1]
6067
0
Query!
Ethics committee country [1]
6067
0
Query!
Date submitted for ethics approval [1]
6067
0
25/09/2008
Query!
Approval date [1]
6067
0
Query!
Ethics approval number [1]
6067
0
Query!
Ethics committee name [2]
6805
0
Central Regional Ethics Committee
Query!
Ethics committee address [2]
6805
0
PO Box 5013
Wellington 6145
Query!
Ethics committee country [2]
6805
0
New Zealand
Query!
Date submitted for ethics approval [2]
6805
0
Query!
Approval date [2]
6805
0
05/03/2009
Query!
Ethics approval number [2]
6805
0
CEN/08/09/053
Query!
Summary
Brief summary
Molluscum contagiosum (MC) is a viral infection of the skin most common on the body, arms, and legs. About one in six children aged one to ten years are infected at some time with MC. Individual lesions go away on their own but only after 6 months to 5 years. Treatment is not always necessary but may be sought for a variety of reasons such as bleeding, secondary infections, itching and discomfort, or for social reasons. There are several treatments, but they are not very effective and can also be painful and expensive. There is some evidence that manuka honey may be beneficial although it has never been studied in this condition before. This study aims to investigate the efficacy of topical manuka honey treatment with simple observation in a group of children with MC
Query!
Trial website
N/A
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
29023
0
Query!
Address
29023
0
Query!
Country
29023
0
Query!
Phone
29023
0
Query!
Fax
29023
0
Query!
Email
29023
0
Query!
Contact person for public queries
Name
12180
0
Kyle Perrin
Query!
Address
12180
0
Level 7 CSB Building
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Query!
Country
12180
0
New Zealand
Query!
Phone
12180
0
+64 4 805 0147
Query!
Fax
12180
0
Query!
Email
12180
0
[email protected]
Query!
Contact person for scientific queries
Name
3108
0
Kyle Perrin
Query!
Address
3108
0
Level 7 CSB Building
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Query!
Country
3108
0
New Zealand
Query!
Phone
3108
0
+64 4 805 0147
Query!
Fax
3108
0
Query!
Email
3108
0
[email protected]
Query!
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF