Condition category
Skin and Connective Tissue Diseases
Date applied
20/10/2011
Date assigned
20/10/2011
Last edited
23/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
The study started in October 2011 and will run until 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
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

When human skin is exposed to ultraviolet radiation (UVR) in sunlight it develops an inflammatory response known as sunburn. This is a major factor for skin damage, premature skin ageing and development of cancer. We have investigated the biochemical mechanisms that influence the development of sunburn and discovered that its early stages are characterised by the time-related production of some very potent 'bioactive' lipid molecules. However, there is a lack of studies on how these molecules contribute to the phasing out and resolution of human skin inflammation.

In this project we want 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.

On 23/07/2013, the anticipated end date was changed from 01/10/2013 to 01/10/2014.

Ethics approval

NRES Committee North West-GM North, 22 August 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 measures

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

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 (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Charity

Funder name

Wellcome Trust (UK) ref: 094028/B/10/Z

Alternative name(s)

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes