An investigation into the barrier function and barrier forming proteins of the skin in polymorphic light eruption
| ISRCTN | ISRCTN44480072 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44480072 |
| Secondary identifying numbers | 17590 |
- Submission date
- 29/10/2014
- Registration date
- 29/10/2014
- Last edited
- 28/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
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
Contact information
Scientific
Photobiology Unit, Hope Hospital , Stott Lane
Salford
M6 8HD
United Kingdom
| mark.farrar@manchester.ac.uk |
Study information
| Study design | Non-randomised; Interventional and Observational; Design type: Not specified, Clinical Laboratory Study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Other |
| Participant 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/ |
| Scientific title | A non-randomised trial investigating the barrier function and barrier forming proteins of the skin in polymorphic light eruption |
| Study objectives | 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(s) | NRES Committee North West - Greater Manchester West; 13/01/2014, ref. 13/NW/0797 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Barrier forming protein function. Timepoint(s): 24h |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 24/02/2014 |
| Completion date | 31/08/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | 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. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/02/2014 |
| Date of final enrolment | 31/08/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
M6 8HD
United Kingdom
Sponsor information
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
"ROR" |
https://ror.org/027m9bs27 |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- BSF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 2016 non-peer-reviewed thesis in https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.684803 (added 25/01/2021) |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/01/2021: Publication reference added to publication and dissemination plan.
12/08/2020: No publications found, verifying study status with principal investigator.
14/09/2017: No publications found, verifying study status with principal investigator.
