Condition category
Skin and Connective Tissue Diseases
Date applied
27/04/2012
Date assigned
27/04/2012
Last edited
26/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Miss Claire Oyston

ORCID ID

Contact details

Institute of Health and Society 4th Floor William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
-
claire.oyston@newcastle.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11799

Study information

Scientific title

Observer blind randomised controlled pilot study comparing localised hand PUVA with localised hand narrowband UVB for the treatment of hand eczema

Acronym

Study hypothesis

This 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

NRES committee North East – Sunderland, 4 April 2012,ref: 12/NE/0033

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Skin; Subtopic: Skin (all Subtopics); Disease: Dermatology

Intervention

76 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The proportion of patients responding (clear or almost clear PGA score) Timepoint(s): 12 weeks

Secondary outcome measures

1. The percentage improvement in the Modified Total Lesion Symptom Score (mTLSS)
2. Dermatology Life Quality Index (DLQI))
3. Health economic evaluation

Overall trial start date

01/08/2012

Overall trial end date

28/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 76; UK Sample Size: 76

Participant exclusion criteria

1. 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

Recruitment start date

01/08/2012

Recruitment end date

28/06/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes