Study to determine the cutaneous irritancy of an ibuprofen patch

• Research type

  Research Study

• Full title

  A double blind, placebo controlled study to determine the cutaneous irritancy of an Ibuprofen patch in healthy volunteers

• IRAS ID

  46310

• Contact name

  Alex Thompson

• Eudract number

  2009-018061-12

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Reckitt Benckiser Healthcare (UK) Limited have developed a locally-applied, locally acting ibuprofen topical patch (medicated plaster) for over-the-counter (OTC) treatment of non-serious, localised pain in the adult population. The active agent in the patch is ibuprofen, a non-steroidal anti inflammatory drug (NSAID. Ibuprofen is well established as a safe and effective OTC treatment for a variety of painful conditions both orally and topically. Ibuprofen exhibits anti-inflammatory, pain relief and anti-fever effects in man by working as a potent (peripheral) blocker (inhibitor) of the cyclooxygenase enzyme system, and is used to treat pain resulting from a wide variety of ailments. There is extensive literature describing the efficacy of ibuprofen. The purpose of this study is to determine the skin reaction on repeated application (cumulative irritancy potential) of the ibuprofen topical patch. While there is no evidence that topical ibuprofen is a significant skin (topical) irritant on repeat use (the range of approved ibuprofen topical products is testimony to this) the topical ibuprofen patch is a novel form of ibuprofen and represents an occlusive dressing. It is thus appropriate to confirm that the new patch formulation is safe in respect of irritancy and to this end an established, Food and Drug Administration (FDA) approved methodology will be adopted.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/10

• Date of REC Opinion

  22 Apr 2010

• REC opinion

  Further Information Favourable Opinion