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

Phase 2

Completed

• Conditions: Acne; Skin - Dermatological conditions

• Registration Number: ACTRN12614000003673
• 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 16-40 years at the time of enrolment
Baseline facial IGA (investigator Global Assessment) of 2 or greater

Exclusion Criteria

Any significant systemic illness
Current requirement for systemic corticosteroid or has had systemic corticosteroid in the 4 weeks prior to Visit 1 Current requirement for oral antibiotic treatment for acne, or has had oral antibiotic treatment for acne in the 4 weeks prior to Visit 1
Current requirement for topical corticosteroid or topical antibiotics for the treatment of acne
Change in oral contraceptive therapy in the last 3 months
A systemic retinoid in the 2 months prior to Visit 1
Known or suspected allergy to honey, or Protex Soap Fresh Antibacterial
Any other condition which, at the investigators 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 Global Assessment (IGA) score for Acne Vulgaris.[At baseline and Week 12 visits]

Secondary Outcome Measures

Name	Time	Method
Mean IGA score[At Week 4 and Week 12 visits];Mean lesion count. Lesion count will be subdivided into inflamed and non-inflamed lesions. Lesions will be graded using the Leeds revised Acne grading system.<br><br>The lesion count will be performed by the blinded investigator.[At Week 4 and Week 12 visits.];Change in subject-rated global Acne improvement using Visual Analogue Score (VAS).[At Week 4 and Week 12 visits];Subject-rated global Acne severity VAS.[At baseline and Week 4 visits];Dermatology Life Quality Index (DLQI)[At baseline, Week 4 and Week 12 visits];Daily self-reported use (applications per day)[Daily for 12 weeks];Weekly self-reported global Acne severity (VAS scale)[Weekly for 12 weeks];Withdrawals due to worsening of acne[At the point of withdrawal]