A Study to Assess the Potential Effects of Diclofenac Spray on Skin

• Research type

  Research Study

• Full title

  A Skin Irritation Study to Assess the Cumulative Irritation Potential of Topical Diclofenac Spray

• IRAS ID

  87204

• Contact name

  Suzana Louth

• Sponsor organisation

  GlaxoSmith Kline Consumer Healthcare

• Eudract number

  2011-002663-26

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and inflammation. In order to reduce the systemic side effects associated with oral diclofenac, a new topical diclofenac spray on patch is being developed for local application that targets delivery of diclofenac to the site of tissue damage. This study will evaluate the skin irritation potential of this new product with currently marketed products and placebo controls once a day for a total of 21 days. At least 35 male and/or female healthy volunteers (aged 18-65 years) will take part in this study. Subjects will be randomised to a treatment sequence to receive all 5 products simultaneously over the 21 day treatment period.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/SC/0375

• Date of REC Opinion

  23 Jan 2012

• REC opinion

  Further Information Favourable Opinion