Study of skin irritancy and sensitisation of an Ibuprofen patch

• Research type

  Research Study

• Full title

  A double blind, placebo controlled study to determine the cutaneous irritancy and sensitisation potential of a topical Ibuprofen patch in healthy volunteers

• IRAS ID

  48783

• Eudract number

  2009-018062-35

• ISRCTN Number

  1

• Research summary

  Reckitt Benckiser Healthcare (UK) Limited has 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 administered orally and topically. Ibuprofen exhibits anti-inflammatory, pain-killing (analgesic) and body temperature lowering (antipyretic) effects in man, and is used to treat pain resulting from a wide variety of ailments. There is extensive literature describing the safety and efficacy of ibuprofen. The purpose of this study is to determine, firstly, the skin reaction to repeated application (cutaneous irritancy) of the ibuprofen patch, and, secondly, the potential for sensitisation to further application of the ibuprofen patch following a 'rest-period' after the repeated application of the ibuprofen patch in the first period of this study. 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), this is a new formulation and it is, therefore, considered appropriate to confirm that it is safe in respect of skin contact sensitisation and, to this end, an established, US Food and Drug Administration (FDA) approved methodology will be adopted.

• REC name

  Wales REC 1

• REC reference

  10/WSE04/22

• Date of REC Opinion

  17 May 2010

• REC opinion

  Further Information Favourable Opinion