Randomised controlled trial of mānuka oil-based ECMT-154™ vs. vehicle control for the topical treatment of eczema, conducted in community pharmacies in New Zealand

Background: Eczema is a chronic skin condition, characterised by inflammation, erythema, and pruritus. Usage of topical therapies containing botanical extracts is common, however evidence of efficacy is often lacking. This trial investigated the safety and efficacy of a mānuka-oil based cream, 2% ECMT-154, versus vehicle control (VC) for the topical treatment of eczema. Methods: This single-blind, parallel group randomised controlled trial was undertaken in 11 community pharmacies across New Zealand. Adults with moderate-to-severe eczema (Patient Oriented Eczema Measure [POEM] ≥ 8 to ≤ 24) were randomised 1:1 to topical 2% ECMT-154 or VC cream, applied twice daily for six weeks. The primary outcome was POEM at week six. Results: 118 participants were recruited between 20th January 2022 and 22nd May 2023. Between baseline and week six mean POEM score (standard deviation) improved from 16.3 (4.2) to 8.8 (5.7) in the ECMT-154 group, and from 16.9 (3.8) to 8.8 (5.7) in the VC group, a between group difference of -0.38 (95% CI: -2.58 to 1.82, p = 0.74). No statistically significant differences were observed across all secondary outcome measures, and no serious adverse events were reported. Conclusions: Whilst symptoms of eczema improved in both treatment groups, there was no evidence of a difference in efficacy between ECMT-154 and VC cream in the treatment of eczema. Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621001096842, the study was registered on 18th of August 2021.