Efficacy and Safety of Clostridium Botulinum Toxin Type A to Improve Appearance of Moderate to Severe Glabellar Lines

PHASE3CompletedINTERVENTIONAL
Enrollment

185

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

April 30, 2015

Study Completion Date

August 31, 2015

Conditions
Moderate to Severe Glabellar Lines
Interventions
BIOLOGICAL

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 A volume of 0.25 mL, containing 50 U of BTX-A-HAC NG (i.e. 10 U/0.05 mL) was withdrawn from the vial into a syringe for administration.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).

DRUG

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 A volume of 0.25 mL was withdrawn from the vial into a syringe for administration.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).

Trial Locations (9)

10707

Rzany & Hund Privatpraxis für Dermatologie, Berlin

20146

University of Hamburg, Hamburg

33200

Nouvelle Clinique Bel Air, Bordeaux

34121

Rote Kreuz Krankenhaus, Kassel

40212

Medical Skin Center, Düsseldorf

75116

Clinique IENA, Paris

82319

Hautzentrum am Starnberger See, Starnberg

06400

Cabinet Medical, Cannes

06160

Mediti, Juan-les-Pins

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ipsen

INDUSTRY