Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:January 23, 2019
End Date:September 2020
Contact:Public Disclosure Manager
Email:clinicaltrials@merz.com
Phone:+49 69 1503 0

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A Prospective, Randomized, Double-blind, Multicenter Study to Investigate the Safety and Duration of Effect of Different NT 201 Dose Groups Following the Treatment of Glabellar Frown Lines

The purpose of the study is to investigate the safety and duration of effect following
different doses of Botulinum Toxin A (NT 201) in the treatment of glabellar frown lines.

This prospective, randomized, double-blind, multi-Center clinical study consists of a two
stage experimental main period comparing different dose groups, followed by an optional
open-label extension (20 Units follow-up treatment).

Inclusion Criteria:

- Male or female subject 18 years or over.

- Moderate (score = 2) to severe (score =3) GFL at maximum frown as assessed by
investigator on the 4-point FWS.

- Moderate (score = 2) to severe (score =3) GFL at maximum frown as assessed by subject
on the 4-point FWS.

Exclusion Criteria:

- Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in the facial area
within the last 12 months before injection.

- Previous treatment with any facial cosmetic procedure (e.g., chemical peeling, photo
rejuvenation, mesotherapy, photodynamic therapy, laser treatment, tattooing of
eyebrows) in the glabellar area within the last 12 months before injection.

- Previous treatment with any biodegradable filler in the glabellar area within the last
12 months before injection.

- Inability to substantially reduce GFL by physically spreading them apart as assessed
by the investigator.

- Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of
the face.

- Any surgery or scars in the glabellar area.

- Marked facial asymmetry.

- Eyelid ptosis.

- Marked brow ptosis and/or dermatochalasis.

- Ongoing severe or unstable medical conditions, e.g., systemic infection, or pulmonary
disease, at the discretion of the investigator.
We found this trial at
6
sites
Nashville, Tennessee 37232
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Berlin,
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San Diego, California 92123
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