Evidence map›Paper›PMID 35197358›Full record

ArticleBMJ open2022

Comparison of ALitretinoin with PUVA as the first-line treatment in patients with severe chronic HAnd eczema (ALPHA): study protocol for a randomised controlled trial.

Isabelle L Smith, Rachael Gilberts, Sarah Brown, Catherine Fernandez, Jane Nixon, Catherine Reynolds, Catherine Smith, John T Lear, Lesley Sunderland, Cathy Green and 7 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 31% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. A new avenue for treatment of chronic hand eczema.The British journal of dermatology · 2022
    Article
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

17 authors at 9 institutions in 5 countries.

Isabelle L SmithClinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK i.l.smith@leeds.ac.uk.
Rachael GilbertsClinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.ORCID 0000-0003-3326-7900
Sarah BrownClinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.
Catherine FernandezClinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.
Jane NixonClinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.
Catherine ReynoldsClinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.
Catherine SmithSt John's Institute of Dermatology, Guy's & St Thomas's NHS Foundation Trust, London, UK.
John T LearDepartment of Dermatology, Salford Royal NHS Foundation Trust, Manchester, UK.
Lesley SunderlandStreet Lane Medical Practice, Leeds, UK.
Cathy GreenDepartment of Dermatology, Ninewells Hospital, Dundee, UK.
Mark GoodfieldDepartment of Dermatology, Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Fiona CowdellFaculty of Health Education and Life Sciences, Birmingham City University, Birmingham, UK.
Philip HamptonDepartment of Dermatology, Newcastle Upon Tyne Hospitals NHS Trust, Newcastle Upon Tyne, UK.
Amy BarkerFaculty of Biological Sciences, University of Leeds, Leeds, UK.ORCID 0000-0003-1626-0934
Armando Vargas-PalaciosAcademic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Sandy TubeufInstitute of Health and Society, Faculté de Santé Publique, Clos Chapelle-aux-Champs, Brussels, Belgium.
Miriam WittmannLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
University of Leeds · GBBirmingham City University · GBChapel Allerton Hospital · GBGuy's and St Thomas' NHS Foundation Trust · GBInstitute of Economic and Social Development · ARLane College · USManchester Academic Health Science Centre · GBNewcastle upon Tyne Hospital · GBNinewells Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHand eczema (HE) is one of the most common skin disorders and an important cause for morbidity and occupational disability. The 1-year prevalence of HE is estimated to be up to 10% and it is estimated that 5%-7% of those develop severe chronic HE. However, current clinical evidence is not compelling enough to guide clinical practice. In a survey among 194 UK dermatologists the most frequent first choice approaches were psoralen combined with ultraviolet A (UVA) treatment (PUVA), oral steroids and alitretinoin (AL). When asked which strategy was most efficient for long-term outcome 20% of clinicians indicated they did not know; 43% of clinicians reported AL and 30% reported PUVA. METHODS AND ANALYSIS: ALPHA is a multicentre, open, prospective, two-arm parallel group, randomised controlled trial comparing PUVA and AL with a planned sample size re-estimation. Between 500 and 780 participants will be randomised on a 1:1 basis. The physician's global assessment (PGA) will direct treatment after randomisation, non-responders will be treated according to usual clinical practice; providing valuable pilot data on second line therapeutic approaches to inform future trials.Assessments will be conducted up to 52 weeks post randomisation. The primary outcome measure is the Hand Eczema Severity Index at 12 weeks. Secondary outcome measures include modified Total Lesion Symptom Score, PGA, time to relapse, patient reported outcome measures and DNA extraction and assessment of genetic variants. A substudy on molecular inflammatory mediators will provide information on subgroup specific treatment responses. Photographs will be taken and HE severity assessed by a central review panel. ETHICS AND DISSEMINATION: Ethics approval was obtained from Leeds West Research Ethics Committee (14/YH/1259).Trial results will be disseminated at relevant clinical conferences and societies, published in peer-reviewed journals and through relevant patient groups. TRIAL REGISTRATION NUMBER: ISRCTN80206075.

Indexed as

EczemaAlitretinoinHumansMulticenter Studies as TopicPatient Reported Outcome MeasuresProspective StudiesRandomized Controlled Trials as TopicAlitretinoindermatologyeczemaoccupational dermatologyphotodermatology

Identifiers

PMID35197358
PMCPMC8867308
OpenAlexW4213419293

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.