Trial Review

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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
Scientific title
The effect of topical honey application on molluscum contagiosum skin lesions
Secondary ID [1] 273402 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
molluscum contagiosum 3810 0
Condition category
Condition code
Skin 3992 3992 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 3530 0
Treatment: Other
Comparator / control treatment
There is no control group, a baseline comparison will be made.
Control group
Uncontrolled

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".
Timepoint [1] 4896 0
After 2 and 4 weeks of treatment
Secondary outcome [1] 8945 0
Parent/caregiver assessment of response after treatment.
Timepoint [1] 8945 0
4 weeks
Secondary outcome [2] 8946 0
Parent/caregiver assessment of treatment acceptability after treatment.
Timepoint [2] 8946 0
4 weeks
Secondary outcome [3] 8947 0
Assessment of compliance with dressing changes.
Timepoint [3] 8947 0
At 2 and 4 weeks.

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
Minimum age
3 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 1258 0
New Zealand
State/province [1] 1258 0

Funding & Sponsors
Funding source category [1] 3992 0
Other
Name [1] 3992 0
Mr Laurence Grieg of Grow Wellington
Country [1] 3992 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Level 7 CSB Building
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 3582 0
Individual
Name [1] 3582 0
Shaun Holt
Address [1] 3582 0
Clinicanz
Level 2 Jesmond House
405 Cameron Road
Tauranga 3140
Country [1] 3582 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6067 0
Ethics committee address [1] 6067 0
Ethics committee country [1] 6067 0
Date submitted for ethics approval [1] 6067 0
25/09/2008
Approval date [1] 6067 0
Ethics approval number [1] 6067 0
Ethics committee name [2] 6805 0
Central Regional Ethics Committee
Ethics committee address [2] 6805 0
PO Box 5013
Wellington 6145
Ethics committee country [2] 6805 0
New Zealand
Date submitted for ethics approval [2] 6805 0
Approval date [2] 6805 0
05/03/2009
Ethics approval number [2] 6805 0
CEN/08/09/053

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
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29023 0
Address 29023 0
Country 29023 0
Phone 29023 0
Fax 29023 0
Email 29023 0
Contact person for public queries
Name 12180 0
Kyle Perrin
Address 12180 0
Level 7 CSB Building
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Country 12180 0
New Zealand
Phone 12180 0
+64 4 805 0147
Fax 12180 0
Email 12180 0
kyle.perrin@mrinz.ac.nz
Contact person for scientific queries
Name 3108 0
Kyle Perrin
Address 3108 0
Level 7 CSB Building
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Country 3108 0
New Zealand
Phone 3108 0
+64 4 805 0147
Fax 3108 0
Email 3108 0
kyle.perrin@mrinz.ac.nz

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
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