Condition(s) treated: Healthy

Intervention: NT 201 (Drug)

Phase: Phase 3

Enrollment status: Recruiting

Sponsor: Merz Pharmaceuticals GmbH

Principal investigator(s) or official(s):
Matthias Imhof, MD, Principal Investigator, Affiliation: Ästhetische Dermatologie, Medico Palais Bad Soden

Overall contact:
Merz Pharmaceuticals, Phone: 49-691-5030, Email: clinicaltrials@merz.de

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.

Official title: 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.

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Investigator`s assessment (Time Frame: 4 weeks after initial injection session)

Minimum eligible age: 18 Years. Maximum eligible age: 65 Years. Eligible gender(s): Both.

Criteria:

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

Merz Pharmaceuticals, Phone: 49-691-5030, Email: clinicaltrials@merz.de

Dr. Matthias Imhof, Medico Palais Bad Soden, Bad Soden, Hessen 65812, Germany; Recruiting
Matthias Imhof, MD, Phone: 49-6196-651-5555, Email: info@aesthetische-dermatologie.eu
Matthias Îmhof, MD, Principal Investigator

Start date: May 2008
End date: November 2008
Last updated: June 9, 2008

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