NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines

PHASE3CompletedINTERVENTIONAL
Enrollment

381

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

April 30, 2009

Study Completion Date

May 31, 2009

Conditions
Glabellar Frown Lines
Interventions
DRUG

NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®))

NT201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), active ingredient: Clostridium botulinum neurotoxin type A free from complexing proteins, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.

DRUG

OnabotulinumtoxinA (Vistabel®)

OnabotulinumtoxinA (Vistabel®), active ingredient: Clostridium botulinum neurotoxin type A, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.

Trial Locations (17)

Unknown

Baden

Krems

Salzburg

Vienna

Bad Soden

Böblingen

Cologne

Darmstadt

Frankfurt

Korschenbroich

Ludwigshafen

Munich

Wuppertal

Glasgow

Manchester

Suttion Coldfield

Winchester

Sponsors
All Listed Sponsors
lead

Merz Pharmaceuticals GmbH

INDUSTRY

NCT00777803 - NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines | Biotech Hunter | Biotech Hunter