SURVEILLANCE STUDY OF PHOTOCONTACT DERMATITIS LEADING TO HOSPITALIZATION IN EUROPE WITH A SPECIAL FOCUS ON TOPICAL KETOPROFEN AND OTHER TOPICAL NSAIDs, INCLUDING EVALUATION OF SEVERE PHOTOSENSITIVITY REACTIONS (KETO1)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  100000096894

  ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS

  100000096930

  ketoprofen
• Medical condition to be studied:
  Photosensitivity reaction

Population studied

• Short description of the study population:
  Patients with following criteria were included:; 1. Age 18-74 years; 2. Consecutive patients of both gender admitted for any of the following acute conditions or elective procedures:; - Acute infection or inflammation*: pneumonia, gastroenteritis, cellulitis, pancreatitis (first episode), otitis media, peritonitis, epididymitis, abscess, meningitis, encephalitis, pelvic inflammatory disease; - Trauma (not related to alcohol or osteoporosis): fractures, sprains/strains, dislocations; - Acute abdominal emergencies*: appendicitis, strangulated hernia, rupture or torsion of an ovarian cyst, acute abdominal pain, ectopic pregnancy, thrombophlebitis (males only, first episode); - Spontaneous pneumothorax; - Alternative diagnoses (when the previous ones are not available): hernias, hallux valgus, cosmetic surgery, deviated nasal septum; * Diagnosis in this group are not all-inclusive, but rather examples of appropriate conditions; - Signed informed consent
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Estimated number of subjects:
  900

Study design details

• Main study objective:
  -to assess the prevalence of exposure to topical NSAIDs in a sample of hospital controls selected as in case-control studies-to develop strict diagnostic criteria for severe photosensitivity-to estimate the incidence of severe photosensitivity leading to hospitalization in selected sampling areas.
• Outcomes:
  -the estimate of prevalence of exposure to topical ketoprofen in the general population. A secondary outcome will be the prevalence of exposure to other topical NSAIDs -The definition of a standard operative procedure for the identification and diagnosis of photosensitivity reactions-The estimate of the incidence of photosensitivity reactions in selected European areas
• Data analysis plan:
  Row and age-standardized prevalence rates together with their 95% confidence intervals (CI) will be calculated for NSAIDs exposure as well as for other variables of interest. Stratification by gender and country will be used for general descriptive statistics as well as for exposure rates. Differences among categories will be tested with Pearson’s chi-squared test or Fisher’s exact test for nominal variables and by Mann-Whitney U test for continuous variables. To estimate possible selection biases in the collection of the sample, a comparison of general characteristics of individuals undergoing the interview and, in particular, their exposure rates to topical NSAIDs, with the expected distribution based on demographic and general sales data obtained from individual areas will be made. Whenever it will be possible risk estimate for exposure will be derived from odds ratio calculation. Multiple logistic regressions will be used to adjust risk estimates for potential confounders.

Documents

Study, other information

Keto1_vers F1 Questionnaire 11-06-2012