Evidence map›Paper›PMID 38287323›Full record

ArticleBMC complementary medicine and therapies2024

Mānuka oil based ECMT-154 versus vehicle control for the topical treatment of eczema: study protocol for a randomised controlled trial in community pharmacies in Aotearoa New Zealand.

Gabrielle Shortt, Nicholas Shortt, Georgina Bird, Kyley Kerse, Nico Lieffering, Alexander Martin, Allie Eathorne, Bianca Black, Bob Kim, Marius Rademaker and 5 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC complementary medicine and therapies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 4 institutions in 2 countries.

Gabrielle ShorttMedical Research Institute of New Zealand, Wellington, Aotearoa, New Zealand. gabby.shortt@mrinz.ac.nz.
Nicholas ShorttMedical Research Institute of New Zealand, Wellington, Aotearoa, New Zealand.
Georgina BirdMedical Research Institute of New Zealand, Wellington, Aotearoa, New Zealand.
Kyley KerseMedical Research Institute of New Zealand, Wellington, Aotearoa, New Zealand.
Nico LiefferingMedical Research Institute of New Zealand, Wellington, Aotearoa, New Zealand.
Alexander MartinMedical Research Institute of New Zealand, Wellington, Aotearoa, New Zealand.
Allie EathorneMedical Research Institute of New Zealand, Wellington, Aotearoa, New Zealand.
Bianca BlackMedical Research Institute of New Zealand, Wellington, Aotearoa, New Zealand.
Bob KimAnderson's Exchange Pharmacy, Dunedin, Aotearoa, New Zealand.
Marius RademakerWaikato Clinical Campus, University of Auckland, Hamilton, Aotearoa, New Zealand.
Louise ReicheNew Zealand Dermatological Society Inc, Palmerston North, Aotearoa, New Zealand.
Selwyn Te PaaMedical Research Institute of New Zealand, Wellington, Aotearoa, New Zealand.
Suki HardingManuka Bioscience Ltd, Auckland, Aotearoa, New Zealand.
Mike ArmourMedical Research Institute of New Zealand, Wellington, Aotearoa, New Zealand.
Alex SempriniMedical Research Institute of New Zealand, Wellington, Aotearoa, New Zealand.
Medical Research Institute of New Zealand · NZVictoria University of Wellington · NZPalmerston North Hospital · NZUniversity of Auckland · NZ

Funding

Callaghan Innovation MBIOS2003
6 · The paper itself

Abstract

backgroundEczema is a chronic, relapsing skin condition commonly managed by emollients and topical corticosteroids. Prevalence of use and demand for effective botanical therapies for eczema is high worldwide, however, clinical evidence of benefit is limited for many currently available botanical treatment options. Robustly-designed and adequately powered randomised controlled trials (RCTs) are essential to determine evidence of clinical benefit. This protocol describes an RCT that aims to investigate whether a mānuka oil based emollient cream, containing 2% ECMT-154, is a safe and effective topical treatment for moderate to severe eczema.

methodsThis multicentre, single-blind, parallel-group, randomised controlled trial aims to recruit 118 participants from community pharmacies in Aotearoa New Zealand. Participants will be randomised 1:1 to receive topical cream with 2% ECMT-154 or vehicle control, and will apply assigned treatment twice daily to affected areas for six weeks. The primary outcome is improvement in subjective symptoms, assessed by change in POEM score. Secondary outcomes include change in objective symptoms assessed by SCORAD (part B), PO-SCORAD, DLQI, and treatment acceptability assessed by TSQM II and NRS. DISCUSSION: Recruitment through community pharmacies commenced in January 2022 and follow up will be completed by mid-2023. This study aims to collect acceptability and efficacy data of mānuka oil based ECMT-154 for the treatment of eczema. If efficacy is demonstrated, this topical may provide an option for a novel emollient treatment. The community-based design of the trial is anticipated to provide a generalisable result. ETHICS AND DISSEMINATION: Ethics approval was obtained from Central Health and Disability Ethics Committee (reference: 2021 EXP 11490). Findings of the study will be disseminated to study participants, published in peer-reviewed journal and presented at scientific conferences.

trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621001096842. Registered on August 18, 2021 ( https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382412&isReview=true ). PROTOCOL VERSION: 2.1 (Dated 18/05/2022).

Indexed as

EczemaPharmaciesAustraliaEmollientsHumansMulticenter Studies as TopicNew ZealandRandomized Controlled Trials as TopicSeverity of Illness IndexEmollientsBotanical therapyDecentralisedEczemaEmollientPharmacy-based research network

Identifiers

PMID38287323
PMCPMC10823637
OpenAlexW4391317479

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.