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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 is a Phase 3 study that has completed, run by Merz North America. The registered enrollment target is 362 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04594213
The ClinicalTrials.gov registry entry for NCT04594213 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 362 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merz North America, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04594213 reports 0 study locations.
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.
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