Study to determine the cutaneous irritancy of an ibuprofen gel

• Research type

  Research Study

• Full title

  A double blind, placebo controlled study to determine the cutaneous irritancy of a 5% Ibuprofen gel in healthy volunteers

• IRAS ID

  46806

• Contact name

  Alex Thompson

• Eudract number

  2009-018063-27

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Reckitt Benckiser Healthcare (UK) Limited have developed a locally-applied, locally acting 5% Ibuprofen topical gel for over-the-counter (OTC) treatment of non-serious, localised pain in the adult population. The active agent in the gel is Ibuprofen, a non-steroidal anti inflammatory drug (NSAID). Ibuprofen is well established as an effective OTC treatment for a variety of painful conditions both administered orally and topically. Ibuprofen exhibits anti-inflammatory, pain-killing (analgesic) and 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 efficacy of ibuprofen. The purpose of this study is to determine the skin reaction on repeated application (cumulative irritancy potential) of the Ibuprofen gel. Whilst there is no evidence that topical Ibuprofen is a significant topical irritant on repeat use (the range of approved Ibuprofen topical products is testimony to this), this is a new formulation and, therefore, it is considered appropriate to confirm that it is safe in respect of irritancy - 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/IEC05/11

• Date of REC Opinion

  22 Apr 2010

• REC opinion

  Further Information Favourable Opinion