ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000004662

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 Rosacea

Scientific title

In adult patients with rosacea will topical medical grade Kanuka honey reduce rosacea severity compared with Cetomacrogol control cream.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1146-6857

Trial acronym

KH06

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Rosacea

Condition category

Condition code

Skin

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 eight weeks. A patient diary will record applications during the treatment period.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The control cream Cetomacrogol applied to the affected facial area twice daily for 30-60 minutes per application, for eight weeks. Kanuka honey will not be used by the control group. Cetomacrogol is a liquid paraffin and white soft paraffin topical emollient, made up of water, petrolatum, Cetearyl Alcohol, mineral oil, Ceteth-20, p-Chloro-m-Cresol.

Control group

Active

Outcomes

Primary outcome [1]

The proportion of subjects who have a 2 or greater improvement in Investigator-rated 7 point Rosacea Severity Score (RSS)

Timepoint [1]

At baseline and Week 8 visits

Secondary outcome [1]

Change in subject-rated Rosacea related quality of life (utilising the Dermatology Quality of Life Index [DLQI])

Timepoint [1]

At baseline, Week 2, and Week 8 visits

Secondary outcome [2]

Subject-rated global Rosacea improvement using a Visual Analogue Score (VAS)

Timepoint [2]

At Week 2 and Week 8 visits

Secondary outcome [3]

Change in subject-related global Rosacea severity using Visual Analogue Score (VAS)

Timepoint [3]

At baseline and Week 2 visits

Secondary outcome [4]

Change in Investigator-rated 7 point Rosacea Severity Score (RSS)

Timepoint [4]

At baseline, Week 2 and Week 8 visits

Secondary outcome [5]

Daily self-reported use (applications per day)

Timepoint [5]

Daily for 8 weeks

Secondary outcome [6]

Weekly self-reported global Rosacea severity (VAS scale)

Timepoint [6]

Weekly for 8 weeks

Secondary outcome [7]

Withdrawals due to worsening of rosacea

Timepoint [7]

At the point of withdrawal

Eligibility

Key inclusion criteria

Aged 16 or over at the time of enrolment
Baseline facial Rosacea Severity Score (RSS) of 2 or greater

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Requirement for systemic corticosteroids, or systemic corticosteroid treatment in the 4 weeks prior to Visit 1 Current requirement for oral or topical antibiotic therapy for rosacea Current requirement for topical corticosteroid treatment for rosacea Known or suspected allergy to honey, or Cetomacrogol control cream Any other condition which, at the investigator's 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 application of topical Kanuka honey cream twice daily or application of topical Cetomacrogol control cream 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 RSS 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-rated Rosacea Severity score at week 8 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

3/02/2014

Actual

4/02/2014

Date of last participant enrolment

Anticipated

3/02/2015

Actual

2/05/2014

Date of last data collection

Anticipated

Actual

Sample size

Target

138

Accrual to date

Final

138

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Honeylab Ltd

Address [1]

Honeylab Ltd
305 Karaka Bay Road
Wellington 6022

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Charities/Societies/Foundations

Name [1]

Medical Research Institute of New Zealand

Address [1]

Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committee

Ethics committee address [1]

1 The Terrace
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

15/08/2013

Approval date [1]

16/10/2013

Ethics approval number [1]

13/CEN/118

Summary

Brief summary

A recent pilot study investigating the use and acceptability of Kanuka honey in Rosacea showed a reduction in severity in 70% of subjects, therefore this study treatment  has the potential to be an effective treatment for Rosacea symptoms. In this study 138 adults with Rosacea will apply either Kanuka honey or Cetomacrogol cream to areas of Rosacea on their face for 30-60 minutes twice a day for 8 weeks.

At baseline and after 2 weeks and 8 weeks the patient's Rosacea will be assessed to look at changes in severity.  Participants will complete a diary for 8 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 rosacea at Visits 2 and 3.

This study will investigate the effectiveness of Kanuka honey in treating rosacea, 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

Braithwaite I, Hunt A, Riley J, et al. Randomised controlled trial of topical kanuka honey for the treatment of rosacea. BMJ Open 2015;5: e007651. doi:10.1136/ bmjopen-2015-007651

Public notes

Contacts

Principal investigator

Name

Prof Richard Beasley

Address

Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242

Country

New Zealand

Phone

+64 4 8050147

Fax

+64 4 3895707

richard.beasley@mrinz.ac.nz

Contact person for public queries

Name

Anna Hunt

Address

Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242

Country

New Zealand

Phone

+64 4 8050147

Fax

+64 4 3895707

anna.hunt@mrinz.ac.nz

Contact person for scientific queries

Name

Anna Hunt

Address

Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242

Country

New Zealand

Phone

+64 4 8050147

Fax

+64 4 3895707

anna.hunt@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

Source	Title	Year of Publication	DOI
Embase	Randomised controlled trial of topical kanuka honey for the treatment of rosacea.	2015	https://dx.doi.org/10.1136/bmjopen-2015-007651

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically