Condition category
Skin and Connective Tissue Diseases
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
11/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4953

Study information

Scientific title

Acronym

Study hypothesis

Examination into the photoprotective potential of topically applied omega-3 fatty acids. Changes in the parameters of short- and long-term UV-damage will be assessed. This includes analysis of the sunburn response, bioavailability of fatty acids, expression of lipid mediators and expression of p53 and collagen.

Ethics approval

MREC approved, ref: 08/H1004/19

Study design

Non-randomised interventional trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Topic: Skin; Subtopic: Skin (all Subtopics); Disease: Dermatology

Intervention

Topical agents containing low doses of omega-3 fatty acids applied to the skin

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

To measure changes in the erythemal response to UVR in the skin

Secondary outcome measures

1. To measure changes in levels of bioactive mediators derived from fatty acids in the skin in response
2. To measure changes in the fatty acid levels in the skin

Overall trial start date

01/04/2008

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. White Caucasian, either sex
2. Aged between 20 and 60 years old
3. Skin type 1 to 3

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 64

Participant exclusion criteria

1. Taking photoactive or anti-inflammatory medication
2. History of photosensitivity
3. History of skin cancer
4. Pregnant or breast feeding
5. Taking omega-3 supplements
6. Sunbathed in past 3 months

Recruitment start date

01/04/2008

Recruitment end date

30/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Photobiology Unit
Salford
M6 8HD
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

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

Funders

Funder type

Research council

Funder name

Biotechnology and Biological Science Research Council (BBSRC) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Croda International Plc (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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