IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines

PHASE3CompletedINTERVENTIONAL
Enrollment

271

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

March 31, 2009

Study Completion Date

June 30, 2009

Conditions
Moderate to Severe Glabellar Frown Lines
Interventions
DRUG

IncobotulinumtoxinA (Xeomin) (20 Units)

The treatment will be administered only once at day 0 at five injection sites in the glabellar area. The total dose of 20 Units IncobotulinumtoxinA (Xeomin) is reconstituted in a total injection volume of 0.5 mL that is to be injected to the five sites in equal aliquots of 0.1 mL.

DRUG

Placebo

The treatment will be administered only once at day 0 at five injection sites in the glabellar area. Volume of Placebo equivalent to IncobotulinumtoxinA (Xeomin).

Trial Locations (8)

33146

Frederic Brandt, Coral Gables

33180

Center for Cosmetic Enhancement, Aventura

46032

Laser & Skin Surgery Center of Indiana, Carmel

60069

Advanced Dermatology Research Institute, Lincolnshire

68144

Joel Schlessinger, Omaha

80113

About Skin Dermatoloy, Englewood

07042

Image Dermatology P.C., Montclair

10604-2926

Rhoda Narins, White Plains

Sponsors
All Listed Sponsors
lead

Merz Pharmaceuticals GmbH

INDUSTRY

NCT00770211 - IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines | Biotech Hunter | Biotech Hunter