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Trial registered on ANZCTR


Registration number
ACTRN12614000003673
Ethics application status
Approved
Date submitted
10/12/2013
Date registered
2/01/2014
Date last updated
9/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A single-blind randomised controlled trial of topical Kanuka honey for the treatment of Acne
Scientific title
In adult patients with Acne will topical medical grade Kanuka honey, in addition to washing with Protex Soap Fresh Antibacterial, reduce acne severity compared with washing with Protex Soap Fresh Antibacterial alone.
Secondary ID [1] 283473 0
None
Universal Trial Number (UTN)
U1111-1146-7415
Trial acronym
KH07
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne 290386 0
Condition category
Condition code
Skin 290779 290779 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topical medical grade Kanuka honey with 10% glycerin content applied to the affected facial area twice daily for 30-60 minutes per application, for twelve weeks. Patients will then wash area with Protex Soap Fresh Antibacterial medicated soap as per manufacturer's instructions, twice daily after honey treatment. A patient diary will record applications during the treatment period.
Intervention code [1] 288184 0
Treatment: Other
Comparator / control treatment
Standard care is Protex Soap Fresh Antibacterial medicated soap. Patients in both arms of the study will wash with Protex Soap Fresh Antibacterial medicated soap twice daily as per manufacturer's instructions. The active ingrediant in Protex Antibacterial Soap is Trichlorocarbanilide 0.7%

Control group
Active

Outcomes
Primary outcome [1] 290778 0
The proportion of subjects who have a 2 or greater improvement in Investigator Global Assessment (IGA) score for Acne Vulgaris.
Timepoint [1] 290778 0
At baseline and Week 12 visits
Secondary outcome [1] 305266 0
Mean IGA score
Timepoint [1] 305266 0
At Week 4 and Week 12 visits
Secondary outcome [2] 305267 0
Mean lesion count. Lesion count will be subdivided into inflamed and non-inflamed lesions. Lesions will be graded using the Leeds revised Acne grading system.

The lesion count will be performed by the blinded investigator.
Timepoint [2] 305267 0
At Week 4 and Week 12 visits.
Secondary outcome [3] 305268 0
Change in subject-rated global Acne improvement using Visual Analogue Score (VAS).
Timepoint [3] 305268 0
At Week 4 and Week 12 visits
Secondary outcome [4] 305269 0
Subject-rated global Acne severity VAS.
Timepoint [4] 305269 0
At baseline and Week 4 visits
Secondary outcome [5] 305270 0
Dermatology Life Quality Index (DLQI)
Timepoint [5] 305270 0
At baseline, Week 4 and Week 12 visits
Secondary outcome [6] 305271 0
Daily self-reported use (applications per day)
Timepoint [6] 305271 0
Daily for 12 weeks
Secondary outcome [7] 305272 0
Weekly self-reported global Acne severity (VAS scale)
Timepoint [7] 305272 0
Weekly for 12 weeks
Secondary outcome [8] 310183 0
Withdrawals due to worsening of acne
Timepoint [8] 310183 0
At the point of withdrawal

Eligibility
Key inclusion criteria
Aged 16-40 years at the time of enrolment
Baseline facial IGA (investigator Global Assessment) of 2 or greater
Minimum age
16 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any significant systemic illness
Current requirement for systemic corticosteroid or has had systemic corticosteroid in the 4 weeks prior to Visit 1 Current requirement for oral antibiotic treatment for acne, or has had oral antibiotic treatment for acne in the 4 weeks prior to Visit 1
Current requirement for topical corticosteroid or topical antibiotics for the treatment of acne
Change in oral contraceptive therapy in the last 3 months
A systemic retinoid in the 2 months prior to Visit 1
Known or suspected allergy to honey, or Protex Soap Fresh Antibacterial
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)
Eligible patients will be randomised into the study. Treatment allocation will be randomised in a 1:1 ratio to receive either washing with Protex Soap Fresh Antibacterial alone, twice daily, or application of topical Kanuka honey prior to washing with Protex Soap Fresh Antibacterial, twice daily. Randomisation envelopes will contain details of treatment allocation per patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Biostatistitian to generate randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Subjects and study site staff will not be blinded to the treatment allocation. An independent investigator at each site will remain blinded to the treatment allocation throughout the study and perform the IGA assessment.
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
We anticipate the proportion of participants in the control group who respond will be between 25 and 50%. A total of 124 participants (62 in each group) has 80% power at 5% significance to detect an absolute difference of 25% responders. Recruitment of 138 participants allows for a 10% drop-out rate.

Logistic regression will be used to test for the difference in response rates defined as the proportion of participants who have greater than or equal to two point improvement in the Investigator Global Assessment score for Acne Vulgaris at week 12 compared to baseline.

The continuous secondary outcome variables will be analysed using ANOVA with baseline readings as a continuous co-variate. Daily self-reported use will be analysed by Poisson regression.

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] 5544 0
New Zealand
State/province [1] 5544 0

Funding & Sponsors
Funding source category [1] 288182 0
Commercial sector/Industry
Name [1] 288182 0
Honeylab Ltd
Address [1] 288182 0
Honeylab Ltd
305 Karaka Bay Road
Wellington 6022
Country [1] 288182 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Honeylab Ltd
Address
Honeylab Ltd
305 Karaka Bay Road
Wellington 6022
Country
New Zealand
Secondary sponsor category [1] 286908 0
None
Name [1] 286908 0
Address [1] 286908 0
Country [1] 286908 0
Other collaborator category [1] 277668 0
Charities/Societies/Foundations
Name [1] 277668 0
Medical Research Institute of New Zealand
Address [1] 277668 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country [1] 277668 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290093 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 290093 0
1 The Terrace
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 290093 0
New Zealand
Date submitted for ethics approval [1] 290093 0
15/08/2013
Approval date [1] 290093 0
16/10/2013
Ethics approval number [1] 290093 0
13/CEN/119

Summary
Brief summary
A recent pilot study using a Kanuka honey product for Acne showed that over 80% of participants self reported improvement, therefore this study treatment has the potential to be an effective treatment for Acne symptoms. In this study 138 adults with Acne will either wash their face with Protex Soap Fresh Antibacterial alone twice daily, or apply topical Kanuka honey to areas of Acne on their face for 30-60 minutes twice a day prior to washing with Protex Soap Fresh Antibacterial for 12 weeks. At baseline and after 4 weeks and 12 weeks the patient's Acne will be assessed to look at changes in severity. Participants will complete a diary for 12 weeks to record their daily treatment applications and weekly severity assessment. Subjects will complete a Dermatology Quality of Life questionnaire at all visits, to note any changes in quality of life. A visual analogue scale will be completed to note any improvement or worsening of a patient's Acne at Visits 2 and 3. This study will investigate the effectiveness of Kanuka honey in treating Acne, potentially improving the health outcomes of those with the condition, and will contribute to the knowledge base around the use of honey for the treatment of skin conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43918 0
Prof Richard Beasley
Address 43918 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 43918 0
New Zealand
Phone 43918 0
+64 4 8050147
Fax 43918 0
+64 4 3895707
Email 43918 0
richard.beasley@mrinz.ac.nz
Contact person for public queries
Name 43919 0
Mrs Anna Hunt
Address 43919 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 43919 0
New Zealand
Phone 43919 0
+64 4 8050147
Fax 43919 0
+64 4 3895707
Email 43919 0
anna.hunt@mrinz.ac.nz
Contact person for scientific queries
Name 43920 0
Mrs Anna Hunt
Address 43920 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 43920 0
New Zealand
Phone 43920 0
+64 4 8050147
Fax 43920 0
+64 4 3895707
Email 43920 0
anna.hunt@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