Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Crows Feet) in Subjects With Moderate to Severe Upper Facial Lines

NCT04622254 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M6020110702019-004113-13
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 12

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.

Conditions

Moderate to Severe Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)

Outcome Measures

Primary Outcomes (3)

• Main Period: Percentage of Glabellar Frown Line (GFL) Responders at Day 30

  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 glabellar lines", 1 is "Mild glabellar lines", 2 is "Moderate glabellar lines", 3 is "Severe glabellar lines" and 4 is "Very severe glabellar lines".

  Day 30

• Main Period: Percentage of Horizontal Forehead Lines (HFL) Responders at Day 30

  The 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. HFL-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 HFL at maximum contraction as assessed by both the investigator and the subject. The MAS for HFL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".

  Day 30

• Main Period: Percentage of Lateral Canthal Lines (LCL) Responders at Day 30

  The 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. LCL-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 both left and right LCL at maximum contraction as assessed by both the investigator and the subject. The MAS for LCL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".

  Day 30

Secondary Outcomes (13)

• 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

  Day 30

• 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

  Day 30

• 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

  Day 30

• 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

  Day 30

• 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

  Day 30

Study Arms (6)

Main Period: Placebo (Group P)

PLACEBO COMPARATOR

Subjects will receive placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period.

Drug: Placebo

Main Period: NT 201 (Group U)

EXPERIMENTAL

Subjects will receive a total of 64 Units (U) of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period.

Drug: NT 201

Main Period: NT 201 and Placebo (Group L)

EXPERIMENTAL

Subjects will receive a total of 24 U NT 201: placebo injection both in the GFL and HFL area, and 24 U NT 201 injection in the LCL area (12 U per side) on Day 1 of main period.

Drug: NT 201; Drug: Placebo

OLEX: NT 201 (Main Period: Group P)

EXPERIMENTAL

Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.

Drug: NT 201

OLEX: NT 201 (Main Period: Group U)

EXPERIMENTAL

Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.

Drug: NT 201

OLEX: NT 201 (Main Period: Group L)

EXPERIMENTAL

Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.

Drug: NT 201

Interventions

NT 201 DRUG

Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Also known as: IncobotulinumtoxinA, Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing protein

Main Period: NT 201 (Group U); Main Period: NT 201 and Placebo (Group L); OLEX: NT 201 (Main Period: Group L); OLEX: NT 201 (Main Period: Group P); OLEX: NT 201 (Main Period: Group U)

Placebo DRUG

Solution for injection prepared by reconstitution of powder with percent (%) Sodium Chloride (NaCl).

Main Period: NT 201 and Placebo (Group L); Main Period: Placebo (Group P)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz North America, Inc.: lead
• Merz Pharmaceuticals GmbH: collaborator

Study Sites (12)

Merz Investigational Site

Bad Soden, 65182, Germany

Location

Merz Investigational Site

Berlin, 10707, Germany

Location

Merz Investigational Site

Bochum, 44793, Germany

Location

Merz Investigational Site

Drensteinfurt, 48317, Germany

Location

Merz Investigational Site

Düsseldorf, 40212, Germany

Location

Merz Investigational Site

Hamburg, 20146, Germany

Location

Merz Investigational Site

Hamburg, 22609, Germany

Location

Merz Investigational Site

Mannheim, 68161, Germany

Location

Merz Investigational Site

München, 80539, Germany

Location

Merz Investigational Site

München, 80636, Germany

Location

Merz Investigational Site

Potsdam, 14467, Germany

Location

Merz Investigational Site

Wuppertal, 42287, Germany

Location

Related Publications (2)

• Pavicic T, Burgess C, Fabi S, Nestor MS, Bee EK, Imhof M, Dersch H, Sudimac V. Aesthetic Improvements Over Time: Long-Term Efficacy and Additional Outcomes of IncobotulinumtoxinA in the Simultaneous Treatment of Upper Facial Lines. J Cosmet Dermatol. 2025 Sep;24(9):e70460. doi: 10.1111/jocd.70460.

  PMID: 40968493 DERIVED

• Joseph J, Sudimac V, Mersmann S, Kerscher M. IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results From Two Randomized, Double-Blind, Placebo-Controlled, Phase III Studies. Aesthet Surg J. 2025 Feb 18;45(3):293-304. doi: 10.1093/asj/sjae222.

  PMID: 39475143 DERIVED

MeSH Terms

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Aesthetics

Aesthetic.Trials@merz.com

+1 984-301-3095

Study Officials

• Merz Medical Expert

  Merz North America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 9, 2020
• Study Start: November 12, 2020
• Primary Completion: June 16, 2021
• Study Completion: July 8, 2022
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12)