Plain English Summary
Background and study aims
When human skin is exposed to sunlight it develops an inflammatory response known as sunburn. This is a major factor for skin damage, premature skin ageing and the development of cancer. We have discovered that very potent fat (lipid) molecules called eicosanoids are produced by the body during the early stages of sunburn. However, there is a lack of studies on how these molecules contribute to resolving skin inflammation. In this study we want to investigate the network of lipids that are responsible for resolving skin inflammation. We wish to study (a) the timing for the production of specific lipids and how this may differ in people who tend to sunburn compared to those who tend to tan, (b) the effect of nutrients contained in fish oils that have been shown to possess sun-protective effects, and to understand (c) how sunlight and nutrients in the diet may affect the manufacture of these lipids and (d) the contribution to this made by different types of skin cells. Understanding how sunburn is resolved will reveal biological markers (biomarkers) related to skin inflammation and can help with the discovery of new treatments.
Who can participate?
Healthy white Caucasian male and female individuals aged between 18 and 60 years.
What does the study involve?
Exposure of the skin on the upper buttock to ultraviolet light (UV), measurements of skin redness, and skin sampling (skin biopsies or skin blisters) from unexposed and UV-exposed areas of the upper buttock. Participants will also take oral omega-3 fatty acid supplements for 3 months.
What are the possible benefits and risks of participating?
Understanding how sunburn is resolved will reveal biomarkers related to skin inflammation and can help with the discovery of new treatments. We do not expect there to be any disadvantage or adverse effect from taking part. You may experience some redness of the skin after the UV exposures. Some discomfort will be felt at the time of skin sampling and in the days following the procedures, which may include redness, irritation and pain at the site. There is also a small risk of infection and bleeding with biopsies. A small permanent scar will be left on your skin at each biopsy site.
Where is the study run from?
The Photobiology Unit at Salford Royal NHS Hospital (Salford, UK).
When is the study starting and how long is it expected to run for?
October 2011 to October 2014.
Who is funding the study?
The Wellcome Trust (UK)
Who is the main contact?
Dr Suzanne Pilkington
Suzanne.pilkington@manchester.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Miss Suzanne Pilkington
ORCID ID
Contact details
Photobiology Unit
Dermatological Sciences
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom
+44 161 275 5368
Suzanne.Pilkington@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10920
Study information
Scientific title
Identifying the network of lipid mediators responsible for maintenance and resolution of ultraviolet radiation-induced skin inflammation
Acronym
Study hypothesis
The aim of this study is to investigate the network of lipids that are responsible for resolving skin inflammation. A study in healthy adult volunteers and patients with abnormal responses to sunlight i.e. photosensitivity, will assess
1. The timing for the production of specific lipids and how this may differ in people who tend to sunburn compared to those who tend to tan
2. How this may differ between healthy people and those showing abnormal clinical responses to sunlight
3. The effect of nutrients contained in fish oils that have been shown to possess sun-protective effects.
Understanding how sunburn is resolved, will increase our understanding of skin inflammation and can facilitate the discovery of new therapeutic agents.
Ethics approval
NRES Committee North West-GM North, 22/08/2011, ref: 11/NW/0567
Study design
Non-randomised, interventional and observational, clinical laboratory study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
GP practices
Trial type
Screening
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
Omega-3 PUFA (Incromega EPA500TG - fish oil supplements rich in omega-3 PUFAs) administered at 4g daily for 3 months
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Concentration of bioactive lipids in skin samples following UVR exposure measured at 3 months
Secondary outcome measures
1. Number of infiltrating inflammatory/immune cells during and until resolution of UVR induced inflammation measured at 3 months
2. The expression of key bioactive lipid metabolising enzymes and receptors in human skin measured at 3 months
Overall trial start date
01/10/2011
Overall trial end date
01/10/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy, human volunteers and patients with defined photosensitivity conditions.
2. Aged 18 - 60 years
3. Sun reactive skin type I - IV (white Caucasian)
4. Both male & female participants
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 125; UK Sample Size: 125
Participant exclusion criteria
1. History of skin cancer
2. Taking photoactive or anti-inflammatory medication
3. Sunbathing, sunbed use or phototherapy in the past 3 months
4. Taking nutritional supplements containing polyunsaturated fatty acids (PUFA)
5. Consuming more than 2 portions of oily fish per week
6. Pregnancy
7. Unable to eat fish or gelatine
Recruitment start date
01/10/2011
Recruitment end date
01/10/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Photobiology Unit, Dermatological Sciences
Salford
M6 8HD
United Kingdom
Sponsor information
Organisation
University of Manchester
Sponsor details
Faculty of Medical and Human Sciences Research Office
3.53 Simon Building
Manchester
M13 9PT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust (UK) ref: 094028/B/10/Z
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
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