Clinical trial NCT03806933: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate to Severe Glabellar Frown Lines
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merz Pharmaceuticals GmbH
First posted: 2019-01-16
Enrollment: 241
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 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).

Eligibility criteria: Inclusion Criteria:

* Male or female participant 18 years or over.
* Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by investigator on the 4-point facial wrinkle scale (FWS).
* Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by participant on the 4-point FWS.

Exclusion Criteria:

* Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in the facial area within the last 12 months before injection.
* Previous treatment with any facial cosmetic procedure (example, chemical peeling, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, tattooing of eyebrows) in the glabellar area within the last 12 months before injection.
* Previous treatment with any biodegradable filler in the glabellar area within the last 12 months before injection.
* Inability to substantially reduce GFL by physically spreading them apart as assessed by the investigator.
* Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of the face.
* Any surgery or scars in the glabellar area.
* Marked facial asymmetry.
* Eyelid ptosis.
* Marked brow ptosis and/or dermatochalasis.
* Ongoing severe or unstable medical conditions, example, systemic infection, or pulmonary disease, at the discretion of the investigator.

Primary outcomes:
measure: Duration of Effect Defined as Time Between Treatment and Relapse to Baseline Status Assessed by the Investigator on the FWS
timeFrame: From the time of first treatment up to Day 360
measure: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
timeFrame: From the time of first treatment up to Day 390
measure: Number of Participants With at Least One Treatment-emergent Serious Adverse Event (TESAE)
timeFrame: From the time of first treatment up to Day 390
measure: Number of Participants With at Least One Treatment-emergent Adverse Event of Special Interest (TEAESI)
timeFrame: From the time of first treatment up to Day 390
measure: Number of Participants With at Least One Treatment Related TEAE
timeFrame: From the time of first treatment up to Day 390
measure: Number of Participants With at Least One Treatment Related TESAE
timeFrame: From the time of first treatment up to Day 390
Secondary outcomes:
measure: Duration of Effect Whereby Effect Was Defined as Score of None (0) or Mild (1) at Maximum Frown as Assessed by the Investigator According to FWS
timeFrame: From the time of first treatment up to Day 360
measure: Duration of Effect Whereby Effect Was Defined by 2-point Improvement From Baseline at Maximum Frown as Assessed by the Investigator According to FWS
timeFrame: From the time of first treatment up to Day 360
measure: Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Investigator's Rating on FWS
timeFrame: At Day 180
measure: Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Participant's Rating on FWS
timeFrame: At Day 180
measure: Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Investigator's Rating on FWS
timeFrame: At Day 180
measure: Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Participant's Rating on FWS
timeFrame: At Day 180
Other outcomes:
Locations:
city: Encino
country: United States
facility: Clinical Testing of Beverly Hills, Merz Investigational Site #0010395
state: California
city: Newport Beach
country: United States
facility: Medical Associates Inc., Merz Investigational Site #0010435
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology, Merz Investigational Site #0010321
state: California
city: San Francisco
country: United States
facility: The Maas Clinics, Merz Investigational Site #0010338
state: California
city: Nashville
country: United States
facility: Tennessee Clinical Research Center, Merz Investigational Site #0010097
state: Tennessee
city: Berlin
country: Germany
facility: Privatpraxis für Dermatologie und Ästhetische Medizin, Merz Investigational Site #0490306
city: Hamburg
country: Germany
facility: Universität Hamburg, Fachrichtung Kosmetik und Körperpflege, Merz Investigational Site #0490095
city: Hamburg
country: Germany
facility: Dermatologische Gemeinschaftspraxis Dr. Prager und Partner, Merz Investigational Site #0490345
city: Potsdam
country: Germany
facility: Skin & Laser Center, Merz Investigational Site #0490362
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Merz Medical Expert
role: STUDY_DIRECTOR
References:
citation: Kerscher M, Fabi S, Fischer T, Gold M, Joseph J, Prager W, Rzany B, Yoelin S, Roll S, Klein G, Maas C. IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines. J Drugs Dermatol. 2021 Oct 1;20(10):1052-1060. doi: 10.36849/JDD.6377.