Clinical Trials

As an evidence-focused company, Manuka Bioscience is running clinical trials to demonstrate the efficacy of its mānuka oil based therapeutic products.

Impetigo Clinical Trial

Impetigo also known as impetigo contagiosa, or school sores, is a bacterial skin infection highly contagious in nature infecting nearly two percent of the world population.

Impetigo is caused by a Staphylococcus aureus or Streptococcus pyogenes bacterial infection on the outer layers of skin, the epidermis

In a 2015 study “The Global Epidemiology of Impetigo” it estimated 162,000,000 people are affected by Impetigo at any one time, the majority in the Oceania region. People living it hot humid climates, in low- and middle-income countries are particularly affected by impetigo.

Trial results from our botanical therapeutics projects identified the strength of mānuka oil against both Staphylococcus aureus and Streptococcus pyogenes which led development of our ECMT154™ topical ointment targeted for the treatment of impetigo.

We commissioned an independent R&D and testing organisation to undertake testing of our mānuka oil-based ointment ECMT-154 as well as “gold standard” topical antibacterial treatments Fusidic Acid antibiotic cream, Crystaderm and Betadine.

In the Zone of Inhibition test (also known as the Disk Diffusion Antibiotic Sensitivity test or the Kirby-Bauer test), a thin film of bacteria applied to a nutrient enriched agar plate is subjected to various antibiotics. The zone of inhibition is a circular area around the antibiotic test sample in which the bacteria colonies do not grow. This test is used to measure the susceptibility of bacteria towards a given antimicrobial product. The diameter of the zone of inhibition is indicative of the efficacy of the specific product. 

The results were impressive.

Zone Inhibition Test Results Demonstrating the Antibacterial Efficacy of Mānuka oil-based Ointment ECMT-154 vs Fusidic Acid Antibiotic Cream, Crystaderm and Betadine

Clinical Trial Results

In May 2021, Manuka Bioscience in partnership with Medical Research Institute of New Zealand began a stage II randomised, single blind, two arm impetigo clinical trial with 50 children aged 2  to 14 years (inclusive).

This 12-month trial compares the efficacy of the topical use of mānuka oil-based ECMT-154 cream with first line antiseptic treatment for impetigo, Crystaderm (containing 1% hydrogen peroxide) in treating non-bullous impetigo.

If you know of any children who are eligible to participate in this trial, please contact gabby.shortt@mrinz.ac.nz.

 

Eczema (Atopic Dermatitis) Clinical Trial

Eczema, also referred to as atopic dermatitis or atopic eczema, is a common chronic inflammatory skin disease characterized by recurrent flares of dry red and itchy skin lesions and subsequent remissions. Pathogenic manifestations of the condition include a defective skin barrier, recurrent infections, and local and systemic type 2 immune responses.

The condition has a considerable impact on quality of life because of skin discomfort and sleep disturbances. Eczema affects up to 30% of children and 10% of adults globally. There is a high prevalence of eczema in developed countries, and an increasing prevalence in developing countries, especially in urbanized areas.

Approximately 230 million people around the world have eczema and the condition does not yet have a permanent cure. Treatment options are limited and are accompanied by unpleasant, sometimes serious side effects.

During the Covid-19 pandemic, recommended strategies to minimise eczema flares included: reducing the usage of immunosuppressants such as steroids and maximising the use of moisturisers and topical anti-inflammatories and antimicrobial agents.

For these reasons, there is a is a significant opportunity to develop new, broad spectrum eczema treatments based on botanical ingredients that combine antimicrobial and anti inflammatory activity such as ECMT-154™.

In December 2021, Manuka Bioscience in partnership with Medical Research Institute of New Zealand will begin a stage II randomised, single blind, two arm eczema clinical trial with 118 patients aged 18-65 years.

This 12-month trial will compare the efficacy of the topical use of mānuka oil-based ECMT-154 TM cream with moisturiser-based vehicle control in treating moderate to severe eczema.

If you would like to participate in this trial, please contact gabby.shortt@mrinz.ac.nz

Clinical Trial Pipeline