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Clinical Phototoxicity and Photogenotoxicity Studies

We administer new drugs and medications to paid volunteers who are randomised. Patients are randomised to receive either drug or placebo or positive control. Small areas of the skin are exposed to specific quantities of light. Skin reactions are assessed and compared with baseline levels. Studies involve systemic or topical agents.

Certain drugs (and other chemicals) that penetrate the skin may cause reactions that occur only when the skin is exposed to light. This is a result of interactions between photons of light and the chemical within the skin. Substances that cause such reactions are usually phototoxic in mechanism.

The skin manifestations of phototoxicity vary and include swelling, redness, blistering and pigmentation. Phototoxicity is not immunologically based and can arise in anyone provided there is enough of the drug and appropriate radiation. Because this has become increasingly important to patients, regulatory authorities and the pharmaceutical industry, photosafety regulatory guidelines were introduced earlier this decade both in Europe and in the USA. Individual drug issues are assessed on a case by case basis with significant flexibility about which laboratory and clinical studies are considered necessary.

In detail, our services comprise:

  • Volunteer phototoxicity studies for topical and systemic drugs

  • Laboratory phototoxicity and photogenotoxicity testing

  • Study design

  • Protocol production and review (in collaboration with sponsor)

  • Ethics submission and approval

  • Obtaining Regulatory approval (if necessary)

  • CRF or eCRF (case report form) design

  • IMP (investigational medicinal product) management

  • Volunteer recruitment and consent

  • Dosing and sampling

  • Data management and recording of results

  • Monitoring and Quality Assurance

  • Interpretation of results, report writing and advice on product labelling and clinical management

  • Accident and Emergency management
 

Web Site Launched

18th April 2008