Safety and Efficacy of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

Merz Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Healthy

Treatments

Drug: NT 201

Study type

Interventional

Funder types

Industry

Identifiers

NCT00694148

2008-000549-73 (EudraCT Number)

MRZ 60201 GL_3001

Details and patient eligibility

About

NT 201 is a Botulinum toxin type A preparation free of complexing proteins. Injected into the muscle, NT 201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is widely used for aesthetic treatment of mimic wrinkles. This study will investigate the safety and efficacy of NT 201 in the treatment of glabellar frown lines.

Enrollment

108 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

moderate to severe glabellar frown lines at maximum frown ((severity score of 2 or 3 on Facial Wrinkle Scale(FWS)as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'
Stable medical condition
Age: between 18 and 65 years (inclusively)

Exclusion criteria

Previous treatment with Botulinum toxin of any serotype in the upper third part of the face within the last 6 month
Previous treatment with biodegradable fillers in the glabellar area within the last 12 month
Previous insertion of permanent material in the glabellar area, including fat graft (regardless of the time between previous treatment and this study)
Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area
Any other planned cosmetic procedure in the upper third part of the face during the trial period
Inability to substantially lessen glabellar frown lines even by physically spreading them apart
Marked facial asymmetry or ptosis of eyelid and/or eyebrow
History of facial nerve palsy
Any infection in the area of the injection sites