MRZ60201/GL/3002: NT 201 in the treatment of glabellar frown lines

• Research type

  Research Study

• Full title

  A prospective, multicenter, randomized, rater- and subjectblind, parallel group trial to investigate the non-inferiority of NT 201, free of complexing proteins, in comparison with Clostridium botulinum toxin type A in the treatment of glabellar frown lines

• IRAS ID

  10425

• Contact name

  Michael Callander

• Sponsor organisation

  Merz Pharmaceutical GmbH

• Eudract number

  2008-002713-40

• ISRCTN Number

  Not Submitted

• Research summary

  The purpose of this clinical study is to show the efficacy and safety of a newly developed drug in the treatment of glabellar frown lines. This drug is named NT 201 and is a so called Botulinum neurotoxin type A. In contrast to existing commercial available kinds of Clostridium Botulinum toxins, NT 201 contains no complexing proteins of clostridial origin, which are potentially immunogenic. NT 201 will be compared with Clostridium Botulinum toxin type A, a drug by which the markedness of glabellar frown lines can be weakened for a certain time period. In this comparison the non-inferiority of NT 201 to Clostridium Botulinum toxin type A in the treatment of glabellar frown lines shall be investigated. The duration of the treatment is 12 weeks plus the duration of the screening period (seven days) for each subject. 384 female subjects between the age of 18 and 50 and with moderate to severe glabellar frown lines will be recruited. The research is funded by Merz Pharmaceuticals GmbH.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  08/H0720/153

• Date of REC Opinion

  11 Dec 2008

• REC opinion

  Further Information Favourable Opinion