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

Study Overview
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Brief Summary
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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
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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.

Conditions
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Healthy

Intervention / Treatment
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* Drug: NT 201


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NT 201|A Botulinum neurotoxin type A, free of complexing proteins Detailed described in study protocol|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's assessment |  | 4 weeks after initial injection session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of glabellar frown lines