3% Kanuka Oil Cream for the Topical Treatment of Eczema

Phase 2

Completed

• Conditions: Eczema; Skin - Dermatological conditions

• Registration Number: ACTRN12618001754235
• Lead Sponsor: Hikurangi Bioactives Limited Partnership

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-25
• Study Completion: 2021-07-06
• Last Update Posted: 5 December 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

•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 Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in POEM scores[Week 6 post-baseline]