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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000004662

Acronym

KH06

Enrollment

138

Registered

2014-01-02

Start date

2014-02-04

Completion date

2014-05-02

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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 applications during the treatment period.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

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

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

Outcome results