Clinical trial NCT04594213: 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
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merz Pharmaceuticals GmbH
First posted: 2020-10-20
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Outpatients (male or female) 18 years of age or older.
* Horizontal forehead lines (HFL), glabellar frown lines (GFL), and symmetrical lateral canthal lines (LCL) of moderate to severe intensity at maximum contraction as assessed by the investigator and subject according to Merz Aesthetics Scales (MAS).

Exclusion Criteria:

* Previous treatment with botulinum neurotoxin (BoNT) of any serotype in the face within the last 12 months before injection.
* Any facial cosmetic procedure within the last 12 months before baseline injection.
* Previous treatment with any biodegradable filler in the face within the last 12 months before injection.
* Any previous insertion of permanent material in the face (regardless of the time between previous treatment and this study).
* Any medical condition that may put the subject at increased risk with exposure to NT201.

Primary outcomes:
measure: Main Period: Percentage of Glabellar Frown Line (GFL) Responders at Day 30
timeFrame: Day 30
measure: Main Period: Percentage of Horizontal Forehead Lines (HFL) Responders at Day 30
timeFrame: Day 30
measure: Main Period: Percentage of Lateral Canthal Lines (LCL) Responders at Day 30
timeFrame: Day 30
Secondary outcomes:
measure: Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for GFL at Maximum Contraction as Assessed by the Investigator at Day 30
timeFrame: Day 30
measure: Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for HFL at Maximum Contraction as Assessed by the Investigator at Day 30
timeFrame: Day 30
measure: Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Investigator at Day 30
timeFrame: Day 30
measure: Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for GFL at Maximum Contraction as Assessed by the Subject at Day 30
timeFrame: Day 30
measure: Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for HFL at Maximum Contraction as Assessed by the Subject at Day 30
timeFrame: Day 30
measure: Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Subject at Day 30
timeFrame: Day 30
measure: Main Period: Global Aesthetic Improvement Scale (GAIS) at Day 30 as Assessed by the Subjects
timeFrame: Day 30
measure: Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 on MAS for GFL at Maximum Contraction as Assessed by the Investigator
timeFrame: Day 30
measure: Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 on MAS for HFL at Maximum Contraction as Assessed by the Investigator
timeFrame: Day 30
measure: Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Investigator
timeFrame: Day 30
measure: Main Period: Global Aesthetic Improvement Scale (GAIS) at Day 30 as Assessed by the Investigator
timeFrame: Day 30
measure: Main Period: Number of Subjects With Related Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 22 Weeks
measure: OLEX Period: Number of Subjects With Related TEAEs
timeFrame: Up to 39 Weeks
Other outcomes:
Locations:
city: Encino
country: United States
facility: Merz Investigational Site
state: California
city: Newport Beach
country: United States
facility: Merz Investigational Site
state: California
city: San Diego
country: United States
facility: Merz Investigational Site
state: California
city: Greenwood Village
country: United States
facility: Merz Investigational Site
state: Colorado
city: Washington
country: United States
facility: Merz Investigational Site
state: District of Columbia
city: Aventura
country: United States
facility: Merz Investigational Site
state: Florida
city: Boca Raton
country: United States
facility: Merz Investigational Site
state: Florida
city: Metairie
country: United States
facility: Merz Investigational Site
state: Louisiana
city: New York
country: United States
facility: Merz Investigational Site
state: New York
city: New York
country: United States
facility: Merz Investigational Site
state: New York
city: New York
country: United States
facility: Merz Investigational Site
state: New York
city: Nashville
country: United States
facility: Merz Investigational Site
state: Tennessee
Study officials:
affiliation: Merz North America, Inc.
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: