Trials / Completed
CompletedNCT03806933
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
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 241 (actual)
- Sponsor
- Merz Aesthetics GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 period (20 Units follow-up treatment).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NT 201 | Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% unpreserved Sodium Chloride (NaCl). |
Timeline
- Start date
- 2019-01-23
- Primary completion
- 2020-09-10
- Completion
- 2020-10-08
- First posted
- 2019-01-16
- Last updated
- 2023-11-15
- Results posted
- 2023-10-04
Locations
9 sites across 2 countries: United States, Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03806933. Inclusion in this directory is not an endorsement.