Randomised controlled trial of topical kanuka honey for the treatment of rosacea

Objective To investigate the efficacy of topical 90% medical-grade kanuka honey and 10% glycerine (Honevo) as a treatment for rosacea.Design Randomised controlled trial with blinded assessment of primary outcome variable.Setting Outpatient primary healthcare population from 5 New Zealand sites.Parti...

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Main Authors: James Fingleton, Mark Weatherall, Richard Beasley, Irene Braithwaite, Janwillem Kocks, Mark Holliday, Andrew Corin, Colin Helm, Davitt Sheahan, Barney Montgomery, Judith Riley, Anna Hunt, Christopher Tofield
Format: Article
Language:English
Published: BMJ Publishing Group 2015-06-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/5/6/e007651.full
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author James Fingleton
Mark Weatherall
Richard Beasley
Irene Braithwaite
Janwillem Kocks
Mark Holliday
Andrew Corin
Colin Helm
Davitt Sheahan
Barney Montgomery
Judith Riley
Anna Hunt
Christopher Tofield
author_facet James Fingleton
Mark Weatherall
Richard Beasley
Irene Braithwaite
Janwillem Kocks
Mark Holliday
Andrew Corin
Colin Helm
Davitt Sheahan
Barney Montgomery
Judith Riley
Anna Hunt
Christopher Tofield
author_sort James Fingleton
collection DOAJ
description Objective To investigate the efficacy of topical 90% medical-grade kanuka honey and 10% glycerine (Honevo) as a treatment for rosacea.Design Randomised controlled trial with blinded assessment of primary outcome variable.Setting Outpatient primary healthcare population from 5 New Zealand sites.Participants 138 adults aged ≥16, with a diagnosis of rosacea, and a baseline blinded Investigator Global Assessment of Rosacea Severity Score (IGA-RSS) of ≥2. 69 participants were randomised to each treatment arm. 1 participant was excluded from the Honevo group, and 7 and 15 participants withdrew from the Honevo and control groups, respectively.Interventions Participants were randomly allocated 1:1 to Honevo or control cream (Cetomacrogol), applied twice daily for 8 weeks.Main outcome measures The primary outcome measure was the proportion of participants who had a ≥2 improvement in the 7-point IGA-RSS at week 8 compared to baseline. Secondary outcomes included change in IGA-RSS and subject-rated visual analogue score of change in severity (VAS-CS) on a 100 mm scale (0 mm ‘much worse’, 100 mm ‘much improved’) at weeks 2 and 8.Results 24/68 (34.3%) in the Honevo group and 12/69 (17.4%) in the control group had a ≥2 improvement in IGA-RSS at week 8 compared to baseline (relative risk 2.03; 95% CI 1.11 to 3.72, p=0.020). The change in IGA-RSS for Honevo compared to control at week 2 minus baseline was −1 (Hodges-Lehman estimate, 95% CI −1 to 0, p=0.03), and at week 8 minus baseline was −1 (Hodges-Lehman estimate, 95% CI −1 to 0, p=0.005). The VAS-CS at week 2 was 9.1 (95% CI 3.5 to 14.7), p=0.002, and at week 8 was 12.3 (95% CI 5.7 to 18.9)¸ p<0.001 for Honevo compared to control.Conclusions Honevo is an effective treatment for rosacea.Trial registration number This trial was registered in the Australian and New Zealand Clinical Trials Registry ACTRN12614000004662.
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spelling doaj-art-b3eba56f5d454f549ee04dda25908fb22025-02-11T22:10:10ZengBMJ Publishing GroupBMJ Open2044-60552015-06-015610.1136/bmjopen-2015-007651Randomised controlled trial of topical kanuka honey for the treatment of rosaceaJames Fingleton0Mark Weatherall1Richard Beasley2Irene Braithwaite3Janwillem Kocks4Mark Holliday5Andrew Corin6Colin Helm7Davitt Sheahan8Barney Montgomery9Judith Riley10Anna Hunt11Christopher Tofield121 Asthma Programme, Medical Research Institute of New Zealand, Wellington, New ZealandRehabilitation, Teaching and Research Unit, University of Otago, Wellington, New Zealand4 Capital & Coast District Health Board, Wellington, New Zealand1 Medical Research Institute of New Zealand, Wellington, New ZealandMedical Research Institute of New Zealand, Wellington, New ZealandMedical Research Institute of New Zealand, Wellington, New ZealandClinical Horizons, Tauranga, New ZealandClinical Horizons, Tauranga, New ZealandPapamoa Pines Medical Centre, Tauranga, New ZealandOptimal Clinical Trials, Auckland, New ZealandMedical Research Institute of New Zealand, Wellington, New ZealandSchool of Psychology, Liverpool John Moores University, Liverpool, UKCameron Medical Clinic, Tauranga, New ZealandObjective To investigate the efficacy of topical 90% medical-grade kanuka honey and 10% glycerine (Honevo) as a treatment for rosacea.Design Randomised controlled trial with blinded assessment of primary outcome variable.Setting Outpatient primary healthcare population from 5 New Zealand sites.Participants 138 adults aged ≥16, with a diagnosis of rosacea, and a baseline blinded Investigator Global Assessment of Rosacea Severity Score (IGA-RSS) of ≥2. 69 participants were randomised to each treatment arm. 1 participant was excluded from the Honevo group, and 7 and 15 participants withdrew from the Honevo and control groups, respectively.Interventions Participants were randomly allocated 1:1 to Honevo or control cream (Cetomacrogol), applied twice daily for 8 weeks.Main outcome measures The primary outcome measure was the proportion of participants who had a ≥2 improvement in the 7-point IGA-RSS at week 8 compared to baseline. Secondary outcomes included change in IGA-RSS and subject-rated visual analogue score of change in severity (VAS-CS) on a 100 mm scale (0 mm ‘much worse’, 100 mm ‘much improved’) at weeks 2 and 8.Results 24/68 (34.3%) in the Honevo group and 12/69 (17.4%) in the control group had a ≥2 improvement in IGA-RSS at week 8 compared to baseline (relative risk 2.03; 95% CI 1.11 to 3.72, p=0.020). The change in IGA-RSS for Honevo compared to control at week 2 minus baseline was −1 (Hodges-Lehman estimate, 95% CI −1 to 0, p=0.03), and at week 8 minus baseline was −1 (Hodges-Lehman estimate, 95% CI −1 to 0, p=0.005). The VAS-CS at week 2 was 9.1 (95% CI 3.5 to 14.7), p=0.002, and at week 8 was 12.3 (95% CI 5.7 to 18.9)¸ p<0.001 for Honevo compared to control.Conclusions Honevo is an effective treatment for rosacea.Trial registration number This trial was registered in the Australian and New Zealand Clinical Trials Registry ACTRN12614000004662.https://bmjopen.bmj.com/content/5/6/e007651.full
spellingShingle James Fingleton
Mark Weatherall
Richard Beasley
Irene Braithwaite
Janwillem Kocks
Mark Holliday
Andrew Corin
Colin Helm
Davitt Sheahan
Barney Montgomery
Judith Riley
Anna Hunt
Christopher Tofield
Randomised controlled trial of topical kanuka honey for the treatment of rosacea
BMJ Open
title Randomised controlled trial of topical kanuka honey for the treatment of rosacea
title_full Randomised controlled trial of topical kanuka honey for the treatment of rosacea
title_fullStr Randomised controlled trial of topical kanuka honey for the treatment of rosacea
title_full_unstemmed Randomised controlled trial of topical kanuka honey for the treatment of rosacea
title_short Randomised controlled trial of topical kanuka honey for the treatment of rosacea
title_sort randomised controlled trial of topical kanuka honey for the treatment of rosacea
url https://bmjopen.bmj.com/content/5/6/e007651.full
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