Status:
COMPLETED
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
Lead Sponsor:
Merz Aesthetics GmbH
Collaborating Sponsors:
Merz Pharmaceuticals GmbH
Conditions:
Moderate to Severe Glabellar Frown Lines
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 (GFL).
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- Male or female participant 18 years or over.
- Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by investigator on the 4-point facial wrinkle scale (FWS).
- Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by participant on the 4-point FWS.
Exclusion
- 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 (example, 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, example, systemic infection, or pulmonary disease, at the discretion of the investigator.
Key Trial Info
Start Date :
January 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2020
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT03806933
Start Date
January 23 2019
End Date
October 8 2020
Last Update
November 15 2023
Active Locations (9)
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1
Clinical Testing of Beverly Hills, Merz Investigational Site #0010395
Encino, California, United States, 91436
2
Medical Associates Inc., Merz Investigational Site #0010435
Newport Beach, California, United States, 92663
3
Cosmetic Laser Dermatology, Merz Investigational Site #0010321
San Diego, California, United States, 92121
4
The Maas Clinics, Merz Investigational Site #0010338
San Francisco, California, United States, 94115