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NCT04594213 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Lateral Canthal Lines) in Subjects With Moderate to Severe Upper Facial Lines
A Phase 3 study, sponsored by Merz North America.
- Completed
- Registry status
- Phase 3
- Development phase
- 362
- Enrollment target
NCT04594213: Completed Phase 3 study, sponsored by Merz North America.
NCT04594213 is a Phase 3 study that has completed, run by Merz North America. The registered enrollment target is 362 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04594213, a Phase 3 study, has completed, sponsored by Merz North America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 362 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the safety and efficacy of NT 201 (active ingredient: Botulinum (neuro)toxin type A, free from complexing proteins) in the combined treatment of wrinkles in the upper face (Upper Facial Lines \[UFL\]): Horizontal Forehead Lines \[HFL\], Glabellar Frown Lines \[GFL\], and Lateral Canthal Lines \[LCL\]). It is a prospective, randomized, double-blind, placebo-controlled, multicenter study with a placebo-control main period (MP) followed by an open-label extension (OLEX) period.
Primary Outcome
The Merz aesthetics scales (MAS) are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. GFL-response was defined as a score of 0 (no) or 1 (mild) and at least two-grade improvement from baseline to Day 30 of main period on MAS for GFL at maximum contraction as assessed by both the investigator and the subject. The MAS for GFL ranged as 0 to 4 where 0 is "No glabe
Interventions
- DRUG Placebo
- DRUG NT 201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2022-05-09 |
| Phase | Phase 3 |
What the finished NCT04594213 record still lists
NCT04594213 is an interventional study that assigns participants to a tested intervention. The registered 362 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04594213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04594213 about?
NCT04594213 is a clinical study titled "Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Lateral Canthal Lines) in Subjects With Moderate to Severe Upper Facial Lines". The purpose of this study is to investigate the safety and efficacy of NT 201 (active ingredient: Botulinum (neuro)toxin type A, free from complexing proteins) in the combined treatment of wrinkles in the upper face (Upper Facial Lines \[UFL\]): Horizontal Forehead Lines \[HFL\], Glabellar Frown Lin...
What is the current status of trial NCT04594213?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 362 participants. The study started on 2020-09-23. Estimated completion is 2022-05-09.
What interventions are being tested in trial NCT04594213?
The interventions under investigation include: Placebo (DRUG), NT 201 (DRUG).
Who is sponsoring clinical trial NCT04594213?
This trial is sponsored by Merz North America, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04594213's enrollment target sits among peer trials
362 1007th of 2000 higher than 993 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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