CompletedPhase 2ACTRN12618001754235

3% Kanuka Oil Cream for the Topical Treatment of Eczema

Randomised Controlled Trial of 3% Kanuka Oil Cream vs Vehicle Control for the Topical Treatment of Eczema

Sponsor

Hikurangi Bioactives Limited Partnership

Enrollment

80 participants

Start Date

May 24, 2019

Study Type

Interventional

Conditions

Eczema

Summary

This study will assess the efficacy of 3% Kanuka Oil cream in the treatment of eczema. The study is designed as a single blind, randomised, vehicle controlled study. 80 participants will be recruited via pharmacies throughout New Zealand and will be randomised 1:1 to receive either 3% Kanuka Oil cream or vehicle control. Participants will be recruited from community pharmacies by pharmacy staff. Pharmacy staff will be trained as investigators by a MRINZ investigator. The baseline visit will consist of screening, consent, demographics, eczema scoring, photo capture of a representative eczema lesion, randomisation and supply of study medication. Participants will be instructed to apply their treatment twice daily for six weeks. Participants will complete a weekly electronic diary for five weeks. The electronic diaries will capture symptom scores, treatment compliance, and adverse events. A paper diary will be offered as a back-up if participants are unable to complete the electronic diary. The paper diary will be returned at the final study visit. The participants will return to the pharmacy at the end of week six for a final study visit. The final visit will consist of eczema scoring, photo capture of a representative eczema lesion, treatment acceptability, adverse event collection, and concomitant medication collection. A survey, two weeks after the final visit, will capture information about adverse events post study treatment. The primary outcome for this study is improvement in patient reported symptoms at six weeks. Secondary outcomes include improvement in patient reported clinical signs, improvement in patient reported quality of life, and inter-rater validity of SCORAD (intensity section) between a blinded dermatologist and pharmacy investigators.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria8

Participant has the ability and willingness to sign a written informed consent using a digital signature or paper form if back up is required
Participant is aged between 18 and 65 years of age, inclusive
Participant reported, Physician diagnosis of eczema
Participant has a POEM category score of ‘moderate or severe eczema’ (8 to 24)
Participant is willing to stop all moisturisers and/or other skin barrier cream or emulsion treatments during the test period and replace with the investigational product assigned in this trial
Participant is willing to replace their body wash and/or soaps with Aqueous cream as supplied at enrolment
Participant is able and willing to attend the follow up visit during the visit window
Participant is able and willing to complete the study and to comply with all study instructions

Exclusion Criteria9

Current requirement for prescription of antibiotics or corticosteroids for the treatment of any condition (with the exception of inhaled corticosteroids)
Use of antibiotics, corticosteroids, calceneurin inhibitors, or antihistamines within the last four weeks (with the exception of inhaled corticosteroids)
Cutaneous mycotic or bacterial disease requiring a topical or systemic therapy
Other skin condition which may affect the assessment of eczema severity
History of allergy or hypersensitivity to the ingredients of the study treatments
Participation in a clinical trial involving an investigational product during the last three months
Participant is pregnant or planning to become pregnant during the study
Known contact with PCR confirmed or probable diagnosis of COVID19 within the last 28 days.•Cold/flu like symptoms, fever, or unexplained shortness of breath in the past 14 days.
Any other condition which, at the investigators’ discretion, it is believed may present a safety risk or impact upon the ability of the participant to complete the study.

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Interventions

3% Kanuka Oil Cream Applied topically, twice daily, for six weeks. The amount applied will vary by eczema spread. Participants are recommended to apply the treatment liberally tot he affected areas.

3% Kanuka Oil Cream Applied topically, twice daily, for six weeks. The amount applied will vary by eczema spread. Participants are recommended to apply the treatment liberally tot he affected areas. A weekly participant diary will be used to monitor adherence.