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

Phase 2

• Conditions: appy Rash; Nappy Rash; Skin - Dermatological conditions

• Registration Number: ACTRN12614000002684
• 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: Stopped early
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

Aged less than 5 years old at the time of enrolment
Doctor’s diagnosis of nappy rash
Nappy Rash Severity Score of 2 or greater

Exclusion Criteria

Current requirement for systemic corticosteroid, systemic anti-fungal or systemic antibiotic treatment, or has had systemic corticosteroid, systemic anti-fungal or systemic antibiotic treatment within 4 weeks prior to Visit 1
Current requirement for topical corticosteroid, topical anti-fungal or topical antibiotic treatment for Nappy Rash
Known or suspected allergy to honey or Bepanthen Nappy Rash Ointment
Any other condition which, at the investigators discretion, it is believed may present a safety risk or impact on the feasibility of the study or the study results

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
appy rash severity score (NRSS) of 1 or greater[Week 2 visit]

Secondary Outcome Measures

Name	Time	Method
Mean NRSS [At baseline and Week 2 visits];Mean parent/caregiver-rated severity using Visual Analogue Score (VAS) [At baseline and Week 2 visits];Parent/caregiver-rated acceptability using Visual Analogue Score (VAS)<br>[Week 2 visit];Parent/Caregiver reported use (mean applications per day)<br>[Daily for 2 weeks];Daily parent/caregiver reported severity (VAS)<br>[Daily for 2 weeks]