Plain English Summary
Background and study aims
Polymorphic light eruption (PLE) is the most common allergy to the sun. It affects 18% of the population of northern Europe. A itchy, but none scarring, skin rash occurs around 4-6 hours after exposure to the sun. Very little is known about what causes PLE. It has been suggested that an allergen formed in or on the skin upon sun exposure is responsible for the rash, but this photoallergen has not yet been identified. Other researchers believe that PLE patients are less likely to suppress the effects of the sun on the skin compared to healthy people. One of the skin's most important roles is to form a barrier between the inside of the body and the environment outside. This barrier is made up of special proteins, which act to prevent water being lost from the skin as well as pathogens entering to the body. Recent work in our laboratory has shown that specific barrier forming proteins of the skin are altered in PLE. A damaged barrier may be more prone to movement of photoallergens through the skin leading to the cause of PLE symptoms. The aim of this study is to investigate the function of the skin barrier in PLE patients before and after exposure to ultraviolet light, and to test the effect of barrier reinforcing molecules on the skin barrier.
Who can participate?
Healthy volunteers or PLE patients who are white caucasians and between 30-60 years old
What does the study involve?
Participants have their sunburn threshold tested on their upper buttock skin. Small skin biopsies are taken from areas exposed to UV light and from unexposed skin for laboratory analysis of skin barrier function. Skin water loss is measured from UV-exposed and unexposed skin.
What are the possible benefits and risks of participating?
Participants do not benefit directly from taking part in this study, but the information gathered will lead to a further understanding of the cause of PLE.
Where is the study run from?
This study is being performed in the Photobiology Unit, Salford Royal NHS Foundation Trust and the dermatology research laboratories at the University of Manchester (UK)
When is the study starting and how long is it expected to run for?
February 2014 to August 2015
Who is funding the study?
British Skin Foundation (UK)
Who is the main contact?
Dr Mark Farrar
mark.farrar@manchester.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mark Farrar
ORCID ID
Contact details
Photobiology Unit
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom
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mark.farrar@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17590
Study information
Scientific title
A non-randomised trial investigating the barrier function and barrier forming proteins of the skin in polymorphic light eruption
Acronym
Study hypothesis
1. The barrier function of the skin is compromised in polymorphic light eruption
2. Abnormal tight junction protein expression is related to skin barrier defects in polymorphic light eruption
3. The barrier can be improved using food-derived molecules
Ethics approval
NRES Committee North West - Greater Manchester West; 13/01/2014, ref. 13/NW/0797
Study design
Non-randomised; Interventional and Observational; Design type: Not specified, Clinical Laboratory Study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Other
Patient information sheet
Details of who to contact can be found at: www.citizenscientist.org.uk/research-opportunities/healthy-volunteers/skin-barrier-and-ultraviolet-light-exposure/
Condition
Topic: Dermatology; Subtopic: Skin (all Subtopics); Disease: Dermatology
Intervention
Measurements of water loss of the skin will be taken from sun protected buttock skin. To assess sunburn threshold, standard minimal erythemal dose (MED) testing will be performed where another area of photoprotected buttock skin will be exposed to twelve controlled doses of UV with each exposure site being approximately 1cm in diameter. Twenty-four hours later, water loss measurements will be repeated and erythema (redness) assessed.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Barrier forming protein function. Timepoint(s): 24h
Secondary outcome measures
Not provided at time of registration
Overall trial start date
24/02/2014
Overall trial end date
31/08/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy volunteers or PLE patients that have reached diagnostic criteria for PLE (through patient questionnaire and clinical diagnosis)
2. White Caucasians of photoreactive skin type I-III
3. Female (not pregnant) or male 30-60 years
4. Volunteers giving written informed consent
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 50; UK Sample Size: 50; Description: To account for drop out rate study team anticipate recruitment between 40-60 participants.
Participant exclusion criteria
1. People who smoke
2. People with other conditions exacerbated by light
3. People taking photoactive medication
4. People unable to complete the visit requirements of the protocol
5. Inability to comply with all requirements of the protocol
6. History of sunbathing or artificial UV exposure in the previous 3 months
7. History of skin cancer
Recruitment start date
24/02/2014
Recruitment end date
31/08/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hope Hospital
Salford
M6 8HD
United Kingdom
Funders
Funder type
Charity
Funder name
British Skin Foundation; Grant Codes: S1004
Alternative name(s)
BSF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
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
Basic results (scientific)
Publication list