Clinical Trials for Eczema Support

Nearly a year ago Zealand Health Manufacturing (our factory in Tauranga) made a product for HoneyLab (now called TRG Pharmaceuticals), which was to be used in a clinical trial.

 We are delighted to report that their clinical study for a proprietary Kanuka oil cream formulation for eczema has been recently published in a highly prestigious journal and the results were outstanding. Shaun explains below about the trial and the results. Maori have traditionally used the Kanuka tree as part of their healing system, Rongoa Maori, and the oil from the Kanuka tree has demonstratable anti-inflammatory and anti-bacterial properties. We formed a partnership and sourced Kanuka oil from Hikurangi Bioactives (Ruatoria, New Zealand). A cream formulation was formulated by the late Kate Robertson and, supported by a grant from Callaghan Innovation, we contracted ZHM to manufacture the eczema cream and placebo for a clinical trial undertaken by the Medical Research institute of New Zealand (MRINZ). The trial was undertaken in 11 research trained community pharmacies across NZ. Eighty adult participants with self-reported moderate-to-severe eczema, who came in for treatment were offered the chance to participate in the trial. They were asked to use either the Kanuka oil cream, or a placebo cream twice daily, for six weeks. The results were measured using the POEM score, which is a patient-rated eczema score from 0-28.

Using this scoring system, eczema is classified in terms of severity as follows.

 • Clear/Almost Clear (0-2); • Mild (3-7); • Moderate (8-16); • Severe (17-24); • Very Severe (25-28) The main result was that patients who used the Kanuka oil cream for six weeks had a POEM score reduction from an average of 18.4 to 6.9. In other words, they went on average from severe to mild. The researchers looked at the proportion of patients using the Kanuka oil cream who had a four or more improvement and it was 94% of the patients. All of these results were clinically and statistically significant compared to the placebo cream (the same cream without the Kanuka oil, which we developed, which also actually gave good results). This was a phase two study with 80 adult patients and we were looking for a signal that it may work. However, the results are so good that we have proven that the cream works and a large phase three study may not be needed. Importantly, as expected, there were no important side effects from using the cream. Another important conclusion from the researchers was that the Kanuka oil cream performed as well as steroid cream (which has lots of side effects, limiting its use, particularly in children) and monoclonal antibodies (which can cost tens of thousands of dollars). At the moment there is no commercial manufacture of their eczema cream and the registration process with Medsafe is underway. We hope that this will be available in 2023 and we are discussing with HoneyLab (TRG) whether we can sell it in the future and will let you know if this happens.