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

In children less than 5 years old with nappy rash will topical medical grade Kanuka honey reduce nappy rash severity compared with Bepanthen Nappy Rash Ointment, and is it acceptable to parents/caregivers.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000002684

Acronym

KH08

Enrollment

138

Registered

2014-01-02

Start date

2014-02-28

Completion date

2014-07-29

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 non-controlled pilot study of the acceptability and feasibility of topical medical grade Kanuka honey for the treatment of Nappy Rash has shown the honey to be an acceptable and potentially effective treatment with a reduction in investigator-rated severity in 60% of participants, therefore this study treatment has the potential to be an effective treatment for Nappy Rash symptoms. In this study 138 children under 5 years of age with Nappy Rash will have applied either Kanuka honey or Bepanthen Nappy Rash Ointment to areas of Nappy Rash at every nappy change for 2 weeks. At baseline and after 2 weeks the patient's Nappy Rash will be assessed to look at changes in severity. At Week 2 visit parent/caregiver acceptability will also be assessed. Participants' parents/caregivers will complete a diary for 2 weeks to record the daily treatment applications and daily severity assessment. This study will investigate the effectiveness of Kanuka honey in treating nappy rash, 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 area at each nappy change for two weeks. There is no protocol-defined time for how long honey is applied at each nappy change. The applied honey will remain in place until the next nappy change. 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

0 to 4 Years

Healthy volunteers

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

Outcome results