LAS41007 for actinic keratosis

• Research type

  Research Study

• Full title

  Double-blind, randomised, vehicle- and comparator-controlled, multicenter trial to evaluate the efficacy and safety of LAS41007 in the treatment of actinic keratosis

• IRAS ID

  65665

• Contact name

  John Thomas Lear

• Sponsor organisation

  Almirall S.A.

• Eudract number

  2010-022244-20

• Research summary

  Actinic keratosis (AK) is a condition involving pre-cancerous blemishes (lesions) caused by excessive exposure to ultraviolet light, including a history of severe sunburns in childhood. The blemishes predominately occur on chronically sun-exposed skin areas in fair-skinned individuals.Treatment of AK commonly involves freezing the lesion, laser therapy or removal of the lesion. Large area treatments can include laser resurfacing, chemical peel or lotions. One of these marketed lotions is Solaraze© containing 3% of the active substance, diclofenac. Solaraze©has been extensively studied and has been shown to be both an effective and safe treatment for patients with AK.In the present study, 5% diclofenac gel (LAS41007) applied twice daily will be compared to Solaraze© 3% gel applied twice daily in order to demonstrate that the higher concentration level is more effective in treating the AK lesions. LAS41007 will also be compared to placebo (dummy medication containing no active ingredient). The safety of the higher concentration of diclofenac in LAS41007 will also be assessed.The study will be conducted in hospital dermatology clinics and GP practices across 50 centres in Germany, UK and Poland. Participants aged 18 years or over, must have 6 to 16 AK lesions and one additional lesion for a small tissue sample on the face, including the forehead and/or on the bald scalp. The lesions should be generally noticeable but may not exceed a certain size. Duration of participation for the entire study totals 15 months, divided into 2 parts.During the first part (treatment), participants will receive LAS41007, Solaraze© or a placebo and will attend the study centre for 6 visits. The treatment period will be 90 days. Treatment success will be assessed 60 days after treatment has stopped. The second part of the study will assess the long-term treatment success at 6 months and 12 months after treatment has stopped.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  10/H1005/89

• Date of REC Opinion

  14 Jan 2011

• REC opinion

  Further Information Favourable Opinion