Topical Treatment of Onychomycosis of the Toenail version 22 April 08

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Vehicle Controlled, Multicentre Study to Evaluate the Safety and Efficacy of SCH 900340 5% Solution Compared with Vehicle Administered Topically in the Treatment of Distal Subungual Onychomycosis of the Toenail

• IRAS ID

  3536

• Contact name

  gamanyarc

• Sponsor organisation

  Schering-Plough Research Institute (A division of Schering Corporation)

• Eudract number

  2007-004331-27

• ISRCTN Number

  N/A

• Research summary

  Onychomycosis is a fungal infection of the nails that is found most commonly on the toes. People with onychomycosis may have difficulty grooming their toenails, damage to socks or stockings, social embarrassment due to the abnormal appearance of their nails, bacterial infections and occasionally pain. Onychomycosis is a difficult fungal infection to treat due to the long time it takes the nail to grow and the inability of current treatments to move through the nail to the infection underneath. Current treatments include those taken by mouth (oral) and those applied to the infected nail or skin (topical). Oral treatments currently give better results, however they are associated with more negative side-effects and therefore are not suitable for certain patients. The treatment to be investigated is SCH 900340 which is being developed for topical treatment. The treatment shows a broad-spectrum anti-fungal action (it acts against a wide range of fungi). Phase 2 trials have shown SCH 900340 is systemically absorbed and also achieves high levels in the nail unit. The aim of this study is to see how effective SCH 900340 is in treating and curing onychomycosis of the toenail. Participants in the study will apply the topical treatment once a day for 48 weeks to their toenail. They will visit their study doctor once every two months for assessments to see whether the onychomycosis is improving.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  08/H1211/128

• Date of REC Opinion

  21 Oct 2008

• REC opinion

  Further Information Favourable Opinion