Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000561886
Ethics application status
Approved
Date submitted
24/04/2012
Date registered
25/05/2012
Date last updated
7/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study of Topical Honey for the Treatment of Eczema
Scientific title
In adult patients with eczema is topical medical-grade honey acceptable and as good as or better than aqueous cream for reducing the severity of eczema lesions?
Secondary ID [1] 280390 0
None
Universal Trial Number (UTN)
U1111-1130-2014
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eczema 286370 0
Condition category
Condition code
Skin 286612 286612 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topical medical grade honey applied to lesion overnight, daily, for 2 weeks. Subjects will apply a thin film of honey sufficient to cover the affected area.
Intervention code [1] 284877 0
Treatment: Other
Comparator / control treatment
Aqueous cream applied to lesion overnight, daily, for 2 weeks. Subjects will apply a thin film of honey sufficient to cover the affected area. Honey will not be used by the control group.

The aqueous cream used will be Aqueous Cream BP, made up of emulsifying ointment 30% and water. The emulsifying ointment is made up of Cetostearyl alcohol 8.1%, Sodium lauryl Sulphate 0.9%, Liquid paraffin 6%, White soft oaraffin 15%, phenoxyethanol 1% and purified water.
Control group
Active

Outcomes
Primary outcome [1] 287023 0
Eczema severity assessed by Intensity component of SCORAD (SCORing Atopic Dermatitis) score
Timepoint [1] 287023 0
At baseline and at final visit after 2 weeks
Secondary outcome [1] 297226 0
Subjective assessment of itch severity, measured by visual analogue score (VAS)
Timepoint [1] 297226 0
At baseline and at final visit after 2 weeks
Secondary outcome [2] 297227 0
Eczema severity assessed by Three Item Severity (TIS) score, a validated scoring system which assesses eczema severity according to the degree of redness, swelling and scratches.
Timepoint [2] 297227 0
At baseline and at final visit after 2 weeks
Secondary outcome [3] 297228 0
Acceptability of honey therapy, measured by VAS
Timepoint [3] 297228 0
At final visit after 2 weeks

Eligibility
Key inclusion criteria
Aged 16 or over at the time of enrolment
Eczema involving the upper limbs
Bilateral lesions, to allow comparison
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Requirement for topical or systemic corticosteroids, as judged by treating doctor
Requirement for antibiotic therapy, as judged by treating doctor
Known or suspected allergy to honey or dressings
Any other condition which, at the investigators discretion, it is believed may present a safety risk or impact the feasibility of the study or the study results

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
7/08/2012
Date of last participant enrolment
Anticipated
Actual
17/10/2012
Date of last data collection
Anticipated
Actual
31/10/2012
Sample size
Target
15
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 4278 0
New Zealand
State/province [1] 4278 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 285157 0
Commercial sector/Industry
Name [1] 285157 0
Honeylab Ltd
Country [1] 285157 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 284020 0
None
Name [1] 284020 0
Address [1] 284020 0
Country [1] 284020 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300615 0
Multi-region ethics committee
Ethics committee address [1] 300615 0
Ethics committee country [1] 300615 0
New Zealand
Date submitted for ethics approval [1] 300615 0
Approval date [1] 300615 0
24/02/2012
Ethics approval number [1] 300615 0
MEC/11/12/098

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2764 2764 0 0
/AnzctrAttachments/362431-Fingleton Kanuka eczema10.1177_2042533313509263.pdf (Publication)

Contacts
Principal investigator
Name 34109 0
Dr James FIngleton
Address 34109 0
Medical Research Institute of New Zealand Private Bag 7902 Wellington 6242
Country 34109 0
New Zealand
Phone 34109 0
+6448051047
Fax 34109 0
Email 34109 0
[email protected]
Contact person for public queries
Name 17356 0
James Fingleton
Address 17356 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 17356 0
New Zealand
Phone 17356 0
+6448050147
Fax 17356 0
Email 17356 0
[email protected]
Contact person for scientific queries
Name 8284 0
James Fingleton
Address 8284 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 8284 0
New Zealand
Phone 8284 0
+6448050147
Fax 8284 0
Email 8284 0
[email protected]

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.