ISRCTN ISRCTN04778461
DOI https://doi.org/10.1186/ISRCTN04778461
Protocol serial number 4953
Sponsor University of Manchester (UK)
Funders Biotechnology and Biological Science Research Council (BBSRC) (UK), Croda International Plc (UK)
Submission date
29/04/2010
Registration date
29/04/2010
Last edited
12/04/2017
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

Not provided at time of registration

Contact information

Miss Suzanne Pilkington
Scientific

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

Study information

Primary study designInterventional
Study designNon-randomised interventional trial
Secondary study designNon randomised controlled trial
Scientific titleOmega 3 fatty acids in skin cell protection from ultraviolet damage
Study objectivesExamination 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(s)MREC approved, ref: 08/H1004/19
Health condition(s) or problem(s) studiedTopic: Skin; Subtopic: Skin (all Subtopics); Disease: Dermatology
InterventionTopical agents containing low doses of omega-3 fatty acids applied to the skin
Intervention typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date30/09/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration64
Key inclusion criteria1. White Caucasian, either sex
2. Aged between 20 and 60 years old
3. Skin type 1 to 3
Key exclusion criteria1. 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
Date of first enrolment01/04/2008
Date of final enrolment30/09/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Photobiology Unit
Salford
M6 8HD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

12/04/2017: No publications found in PubMed, verifying study status with principal investigator.