CompletedPhase 2ACTRN12614000004662

A single-blind randomised controlled trial of topical Kanuka honey for the treatment of Rosacea

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

Sponsor

Honeylab Ltd

Enrollment

138 participants

Start Date

Feb 4, 2014

Study Type

Interventional

Conditions

Rosacea

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.

Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Inclusion Criteria2

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

Exclusion Criteria1

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

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Interventions

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 applicatio

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.