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Trial registered on ANZCTR


Registration number
ACTRN12612000562875
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 Psoriasis
Scientific title
In adult patients with psoriasis is topical medical-grade honey acceptable and as good as or better than aqueous cream for reducing the severity of psoriasis lesions?
Secondary ID [1] 280391 0
None
Universal Trial Number (UTN)
U1111-1130-2111
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 286371 0
Condition category
Condition code
Skin 286613 286613 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topical medical grade honey applied to lesion overnight for 2 weeks. Subjects will apply sufficient honey to form a thin film over the affected area.
Intervention code [1] 284876 0
Treatment: Other
Comparator / control treatment
Aqueous cream applied to lesion overnight for 2 weeks. Subjects will apply sufficient honey to form a thin film over 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] 287025 0
Psoriasis severity assessed by intensity component of PASI (Psoriasis Area and Severity Index)
Timepoint [1] 287025 0
At baseline and at final visit after 2 weeks
Secondary outcome [1] 297230 0
Subjective assessment of lesion severity, measured by visual analogue score (VAS)
Timepoint [1] 297230 0
At baseline and at final visit after 2 weeks
Secondary outcome [2] 297231 0
Acceptability of honey therapy, measured by VAS
Timepoint [2] 297231 0
At final visit after 2 weeks

Eligibility
Key inclusion criteria
Aged 16 or over at the time of enrolment
Psoriasis involving the upper or lower limbs
Bilateral lesions, to allow comparison
Minimum age
16 Years
Maximum age
No limit
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4279 0
New Zealand
State/province [1] 4279 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 285158 0
Commercial sector/Industry
Name [1] 285158 0
Honeylab Ltd
Address [1] 285158 0
Honeylab Ltd
305 Karaka Bay Road
Wellington 6022
Country [1] 285158 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] 284021 0
None
Name [1] 284021 0
Address [1] 284021 0
Country [1] 284021 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300613 0
Multi-region ethics committee
Ethics committee address [1] 300613 0
Ethics committee country [1] 300613 0
New Zealand
Date submitted for ethics approval [1] 300613 0
Approval date [1] 300613 0
04/05/2012
Ethics approval number [1] 300613 0
MEC/12/03/022

Summary
Brief summary
There are reasons to believe that medical grade-honey applied directly to skin may be an effective treatment for psoriasis. In this study 15 adults with psoriasis will apply honey to an psoriasis lesion on one arm and aqueous cream to a matched lesion on the other overnight, every night for two weeks.

After two weeks the lesions will be assessed to look at changes in severity. Participants will also be asked about their experience of using honey.

This trial will provide useful information on the practicalities of topical honey as a treatment for psoriasis. It will also give an initial signal as to whether honey may be effective.
Trial website
Trial related presentations / publications
JRSM Open. 2014 Feb 26;5(3):2042533313518913. doi: 10.1177/2042533313518913. eCollection 2014 Mar.
A randomised controlled trial of topical Kanuka honey for the treatment of psoriasis.
Fingleton J1, Sheahan D2, Corin A3, Weatherall M4, Beasley R5.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4012670/
Public notes

Contacts
Principal investigator
Name 34110 0
Dr James Fingleton
Address 34110 0
Medical Research Institute of New Zealand Private Bag 7902 Wellington 6242
Country 34110 0
New Zealand
Phone 34110 0
+6448051047
Fax 34110 0
Email 34110 0
james.fingleton@mrinz,ac,nz
Contact person for public queries
Name 17357 0
Dr James FIngleton
Address 17357 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 17357 0
New Zealand
Phone 17357 0
+6448050147
Fax 17357 0
Email 17357 0
James.Fingleton@mrinz.ac.nz
Contact person for scientific queries
Name 8285 0
Dr James Fingleton
Address 8285 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 8285 0
New Zealand
Phone 8285 0
+6448050147
Fax 8285 0
Email 8285 0
James.Fingleton@mrinz.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary