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
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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
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