Our Services

Pharmaceutical

Drug phototoxicity is defined as an abnormal sensitivity of the skin to sunlight or artificial light sources due to interaction between photons and a therapeutic agent within the skin. It is non immunologically based and can arise in any individual providing there is enough of the drug and appropriate radiation to cause the problem. The skin manifestations are varied with swelling, redness, blistering, pigmentation, accelerated skin ageing and on rare occasions skin cancer. This issue has become increasing important to patients, regulatory authorities and the pharmaceutical industry. Photosafety regulatory guidelines were introduced earlier this decade from Europe and the USA. Individual drug issues are assessed on a case by case basis with a significant element of flexibility as to laboratory and clinical studies considered to be necessary.

Professor James Ferguson has developed an evidence based methodology for studying phototoxicity in clinical volunteers. Over the years a substantial expertise in considering the need or otherwise for such work has been established Clinical phototoxicity trials are conducted on healthy volunteers using the drugs or product supplied by industry and tested for phototoxicity. The results will be analysed and reported back to the trial sponsor.

Phototoxicity testing is carried out on the premises of the National Photobiology Unit, Ninewells Hospital and Medical School (part of NHS Tayside).

Full phototoxicity services comprise:

• Volunteer phototoxicity studies for topical and systemic drugs
• Laboratory phototoxicity and photogenotoxicity testing
• Scientific input
• Study design
• Protocol production and review (in collaboration with sponsor)
• Ethics submission and approval
• Regulatory approval (if necessary)
• CRF design
• IMP management
• Subject recruitment and consent
• Dosing and sampling
• Phototesting and recording of results
• Accident and Emergency management
• Monitoring and Q&A
• Data management
• Interpretation of results
• Report production and review