Lipid mediators of ultraviolet radiation (UVR) induced skin inflammation

ISRCTN	ISRCTN47896115
DOI	https://doi.org/10.1186/ISRCTN47896115
Secondary identifying numbers	10920

Submission date: 20/10/2011
Registration date: 20/10/2011
Last edited: 18/01/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Miss Suzanne Pilkington
Scientific

Photobiology Unit, Dermatological Sciences
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom

Phone	+44 161 275 5368
Email	Suzanne.Pilkington@manchester.ac.uk

Study information

Study design	Non-randomised, interventional and observational, clinical laboratory study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	GP practice
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Identifying the network of lipid mediators responsible for maintenance and resolution of ultraviolet radiation-induced skin inflammation
Study objectives	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(s)	NRES Committee North West-GM North, 22/08/2011, ref: 11/NW/0567
Health condition(s) or problem(s) studied	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
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 study start date	01/10/2011
Completion date	01/10/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 125; UK Sample Size: 125
Key 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
Key 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
Date of first enrolment	01/10/2011
Date of final enrolment	01/10/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Photobiology Unit, Dermatological Sciences

Salford
M6 8HD
United Kingdom

Sponsor information

University of Manchester
University/education

Faculty of Medical and Human Sciences Research Office
3.53 Simon Building
Manchester
M13 9PT
England
United Kingdom

Website	http://www.manchester.ac.uk/
"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Charity

Wellcome Trust (UK) ref: 094028/B/10/Z
Private sector organisation / International organizations

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	Not provided at time of registration
IPD sharing plan

Editorial Notes

18/01/2017: No publications found in PubMed, verifying study status with principal investigator.
23/07/2013: The anticipated end date was changed from 01/10/2013 to 01/10/2014.