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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/28279
• EU PAS number:
  EUPAS2679
• Study ID:
  28279
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  France

  Italy
• Study description:
  Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic effects. Topical ketoprofen is used in more than 70 countries worldwide. In spite of having been associated with photocontact dermatitis, limited data are available on incidence rate of reactions leading to hospitalization and on risk factor for the reaction.As requested by EMA in 2010 (procedure No. EMEA/H/A-107/1259) and to better evaluate the risk and benefit profile of topical ketoprofen, an epidemiologic case-control study was proposed focusing on severe photosensitivity reactions leading to hospitalization and assessing risks linked to the use of topical ketoprofen and other topical NSAIDs. The study will be conducted on a Europe-wide scale and requires that clear assumptions are made about exposure rates, criteria to define cases of severe photosensitivity, and incidence of severe photosensitivity reactions.To assess the feasibility of such a case-control study before embarking into a Europe-wide large-scale endeavor, a pilot study will be conducted focusing on incidence rates of severe photosensitivity reactions leading to hospitalization, and prevalence of exposure to topical ketoprofen among controls. These pieces of information will be used to estimate the sample size and the statistica power of the case control study. The pilot phase will also address methodological issues granting validity to the study, including standardization of diagnostic criteria and comparison between exposure among controls and exposure in the underlined at risk population so that indirect methods to assess attributable risks could be applied in the case control study.Centers in three geographic areas, intended to represent the variety of Europe in terms of different rates of exposure to topical NSAIDs and of incidence of photosensitivity reactions, will participate to this pilot study (Lombardy region, Paris metropolitan area, Prague metropolitan area).
• Study status:
  Finalised

Research institutions and networks

Institutions

Centro Studi GISED

Italy

UPEC-Université Paris-Est Créteil Val de Marne Paris, France, 2nd Medical School, Charles University Prague, Czech Republic

Networks

REACT

Study timelines

Date when funding contract was signed

Actual: 24/04/2012

Study start date

Planned: 01/09/2012

Actual: 02/10/2012

Data analysis start date

Planned: 15/11/2012

Actual: 15/11/2012

Date of interim report, if expected

Planned: 01/12/2012

Actual: 06/12/2012

Date of final study report

Planned: 30/04/2013

Actual: 05/11/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Menarini, Bayer SpA, Cyathus, Dompè SpA, EG SpA, JSC Grindeks, Hisamitsu Ltd, Istituto Biochimico Italiano, Italfarmaco SpA, Pierre Fabre, Sanofi-Aventis, Sandoz

Study protocol

Initial protocol

Ketoprofen_-_Pilot_phase_Protocol_F.1_11-06-2012[1]

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)