Project Bronson cumulative irritancy study (non-occlusive)

• Research type

  Research Study

• Full title

  A randomised, double blind non-occlusive comparative study to determine the cutaneous irritancy of a 5% Ibuprofen gel in healthy volunteers

• IRAS ID

  66398

• Contact name

  Alex Thompson

• Eudract number

  2010-023148-34

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Reckitt Benckiser have developed a new 5% ibuprofen topical gel for the relief of mild pain in over-the-counter (OTC) indications. The purpose of this study is to determine the skin reaction to repeated application (cumulative irritancy potential) of the Ibuprofen gel when applied under non-occlusive conditions. Whilst there is no evidence that topical Ibuprofen applied under non-occlusive conditions 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.The study has been designed to reflect the anticipated application schedule (i.e., administered according to a typical on pack instructions for ibuprofen gel products). The Ibuprofen gel will therefore be applied to a designated area of the subjects back, three times per day for 21 consecutive days. Dermal irritancy scores will be recorded prior to each application to give an indication of the cumulative irritancy of the product. The primary endpoint will be the skin reaction, mean scores at each of the sixty five skin assessments, calculated from the individual assessments recorded by the assessor. Throughout the study, AEs and concomitant medications will be sought.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/33

• Date of REC Opinion

  3 Nov 2010

• REC opinion

  Further Information Favourable Opinion