185
Participants
Start Date
January 31, 2015
Primary Completion Date
April 30, 2015
Study Completion Date
August 31, 2015
Botulinum toxin type A
A solution containing 50 U in 0.25 mL (200 U/mL). Each vial contained 0.625 mL of deliverable volume of solution. A volume of 0.25 mL, containing 50 U of BTX-A-HAC NG (i.e. 10 U/0.05 mL) was withdrawn from the vial into a syringe for administration. The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection), each of which was to be administered into predefined sites across the glabellar region (two injections into each corrugator muscle and one injection into the procerus muscle).
Placebo
A solution containing only the excipients of BTX-A-HAC NG (identical in appearance to the active product). Each vial contained 0.625 mL of deliverable volume of solution. A volume of 0.25 mL was withdrawn from the vial into a syringe for administration. The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection), each of which was to be administered into predefined sites across the glabellar region (two injections into each corrugator muscle and one injection into the procerus muscle).
Rzany & Hund Privatpraxis für Dermatologie, Berlin
University of Hamburg, Hamburg
Nouvelle Clinique Bel Air, Bordeaux
Rote Kreuz Krankenhaus, Kassel
Medical Skin Center, Düsseldorf
Clinique IENA, Paris
Hautzentrum am Starnberger See, Starnberg
Cabinet Medical, Cannes
Mediti, Juan-les-Pins
Lead Sponsor
Ipsen
INDUSTRY