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

Phase 2

Completed

• Conditions: Rosacea; Skin - Dermatological conditions

• Registration Number: ACTRN12614000004662
• Lead Sponsor: Honeylab Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of subjects who have a 2 or greater improvement in Investigator-rated 7 point Rosacea Severity Score (RSS)[At baseline and Week 8 visits]

Secondary Outcome Measures

Name	Time	Method
Change in subject-rated Rosacea related quality of life (utilising the Dermatology Quality of Life Index [DLQI])[At baseline, Week 2, and Week 8 visits];Subject-rated global Rosacea improvement using a Visual Analogue Score (VAS)[At Week 2 and Week 8 visits];Change in subject-related global Rosacea severity using Visual Analogue Score (VAS) [At baseline and Week 2 visits];Change in Investigator-rated 7 point Rosacea Severity Score (RSS) [At baseline, Week 2 and Week 8 visits];Daily self-reported use (applications per day)[Daily for 8 weeks];Weekly self-reported global Rosacea severity (VAS scale)[Weekly for 8 weeks];Withdrawals due to worsening of rosacea[At the point of withdrawal]