Study comparing localised hand psoralen immersion combined with ultraviolet A (PUVA) with localised hand narrowband ultraviolet B (UVB) for the treatment of hand eczema

ISRCTN ISRCTN18213910
DOI https://doi.org/10.1186/ISRCTN18213910
Secondary identifying numbers 11799
Submission date
27/04/2012
Registration date
27/04/2012
Last edited
26/08/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
This study aims to compare two types of phototherapy (light therapy) for patients with hand eczema. PUVA treatment (psoralen immersion combined with UVA light) is often used for eczema that does not respond to topical treatments. However, PUVA has disadvantages and an alternative treatment is narrow band UVB light treatment (NB UVB), which has been effectively used for whole body eczema. This study aims to provide data to plan a definitive trial of PUVA versus NB UVB for treatment of hand eczema.

Who can participate?
Patients with any type of hand eczema affecting the palmar skin who have been referred for PUVA.

What does the study involve?
Participants will attend phototherapy sessions twice per week for a maximum of 14 weeks. Participants will be randomly allocated to one of two groups. Group 1 will receive NB UVB phototherapy to the hands (i.e., their hands will be exposed to UVB light). Group 2 will receive PUVA phototherapy to the hands (i.e., their hands will be soaked in a diluted solution of psoralen and then exposed to UVA light).

What are the possible benefits and risks of participating?
Possible benefits include improvement of symptoms. There are no known risks of participating in the study.

Where is the study run from?
The Newcastle upon Tyne Hospitals NHS Foundation Trust – Royal Victoria Infirmary (UK).

When is the study starting and how long is it expected to run for?
The study is due to commence in August 2012. Recruitment will last for 15 months.

Who is funding the study?
NIHR Research for Patient Benefit.

Who is the main contact?
Claire Oyston (Trial Manager)
Claire.oyston@ncl.ac.uk

Contact information

Miss Claire Oyston
Scientific

Institute of Health and Society 4th Floor William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Email claire.oyston@newcastle.ac.uk

Study information

Study designRandomised; Interventional; Design type: Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleObserver blind randomised controlled pilot study comparing localised hand PUVA with localised hand narrowband UVB for the treatment of hand eczema
Study objectivesThis study aims to compare two types of phototherapy for patients with hand eczema. Some previous research has suggested that narrow band UVB light treatment may be as effective for hand eczema as PUVA. Therefore this pilot study will assess the feasibility and refine the methodology for a large multicentre study of PUVA vs narrowband UVB for the treatment of hand eczema. Specifically we will look at the recruitment, retention and response rates of patients. Also test the integrity of the study protocol and pilot the collection of the primary and secondary outcome measures.

More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=11799
Ethics approval(s)NRES committee North East – Sunderland, 4 April 2012,ref: 12/NE/0033
Health condition(s) or problem(s) studiedTopic: Skin; Subtopic: Skin (all Subtopics); Disease: Dermatology
Intervention76 participants will be randomised to two groups:

Group 1 will receive narrow band UVB phototherapy to the hands. Hands will be exposed to UVB light.

Group 2 will receive PUVA phototherapy to the hands. Hands will be soaked in a diluted solution of Psoralen and the exposed to UVA light.
Intervention typeOther
Primary outcome measureThe proportion of patients responding (clear or almost clear PGA score) Timepoint(s): 12 weeks
Secondary outcome measures1. The percentage improvement in the Modified Total Lesion Symptom Score (mTLSS)
2. Dermatology Life Quality Index (DLQI))
3. Health economic evaluation
Overall study start date01/08/2012
Completion date28/06/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 76; UK Sample Size: 76
Key inclusion criteria1. Patient has provided written informed consent for participation in the study prior to any study specific procedures
2. Palmar eczema not responding to topical treatments
3. Over 18 years of age
4. No topical treatments (except emollients for 48 hours)
5. No systemic treatments for eczema treatment for 3 months
6. Absence of clinical evidence of bacterial, fungal or viral infection
7. Not pregnant
8. Target Gender: Male & Female
Key exclusion criteria1. Inability to give informed consent
2. Significant eczema on the dorsal surface of the hands
3. Previous phototherapy within the last 3 months
4. Previous sunbed use within the last 3 months
5. Current involvement in other investigational studies or trials, or involvement within 3 months prior to study entry
Date of first enrolment01/08/2012
Date of final enrolment28/06/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Institute of Health and Society 4th Floor William Leech Building
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Leazes Wing, Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom

ROR logo "ROR" https://ror.org/05p40t847

Funders

Funder type

Government

National Institute of Health Research (NIHR) - Research for Patient Benefit [RfPB] (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan