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

Moderate to Severe Glabellar Frown Lines Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03806933
• Other study ID #: M602011015
• Secondary ID: 2018-002743-28
• Status: Completed
• Phase: Phase 2
• Start date: January 23, 2019
• Est. completion date: October 8, 2020

Study information

• Verified date: November 2023
• Source: Merz North America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: October 8, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Moderate to Severe Glabellar Frown Lines

Intervention

Drug:
• NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% unpreserved Sodium Chloride (NaCl).

Locations

Country	Name	City	State
Germany	Privatpraxis für Dermatologie und Ästhetische Medizin, Merz Investigational Site #0490306	Berlin
Germany	Dermatologische Gemeinschaftspraxis Dr. Prager und Partner, Merz Investigational Site #0490345	Hamburg
Germany	Universität Hamburg, Fachrichtung Kosmetik und Körperpflege, Merz Investigational Site #0490095	Hamburg
Germany	Skin & Laser Center, Merz Investigational Site #0490362	Potsdam
United States	Clinical Testing of Beverly Hills, Merz Investigational Site #0010395	Encino	California
United States	Tennessee Clinical Research Center, Merz Investigational Site #0010097	Nashville	Tennessee
United States	Medical Associates Inc., Merz Investigational Site #0010435	Newport Beach	California
United States	Cosmetic Laser Dermatology, Merz Investigational Site #0010321	San Diego	California
United States	The Maas Clinics, Merz Investigational Site #0010338	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Merz Aesthetics GmbH	Merz Pharmaceuticals GmbH

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Effect Defined as Time Between Treatment and Relapse to Baseline Status Assessed by the Investigator on the FWS	Duration of effect: time between treatment and first occurrence of relapse to baseline status. If no effect was observed, duration of effect was set to 0. Effect: any improvement (at least 1 point) at maximum frown as assessed by investigator on FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible [that is, visible furrows]), 2 (moderately strong muscle action possible [that is, visible muscle bulges]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95 percent (%) confidence interval (CI) were calculated using log-log transformation.	From the time of first treatment up to Day 360
Primary	Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)		From the time of first treatment up to Day 390
Primary	Number of Participants With at Least One Treatment-emergent Serious Adverse Event (TESAE)		From the time of first treatment up to Day 390
Primary	Number of Participants With at Least One Treatment-emergent Adverse Event of Special Interest (TEAESI)		From the time of first treatment up to Day 390
Primary	Number of Participants With at Least One Treatment Related TEAE		From the time of first treatment up to Day 390
Primary	Number of Participants With at Least One Treatment Related TESAE		From the time of first treatment up to Day 390
Secondary	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	Duration of effect was defined as time between treatment and first point in time when score was moderate or severe again. If no effect was observed, duration of effect was set to 0. Effect was defined by a score of none (0) or mild (1) at maximum frown as assessed by investigator according to FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible [that is, visible furrows]), 2 (moderately strong muscle action possible [that is, visible muscle bulges]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95% CI were calculated using log-log transformation.	From the time of first treatment up to Day 360
Secondary	Duration of Effect Whereby Effect Was Defined by 2-point Improvement From Baseline at Maximum Frown as Assessed by the Investigator According to FWS	Duration of effect: time between treatment and first point in time when improvement was less than 2 points again. If no effect was observed, duration of effect was set to 0. Effect: at least a 2-point improvement from baseline at maximum frown as assessed by investigator on the FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible [that is, visible furrows]), 2 (moderately strong muscle action possible [that is, visible muscle bulges]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95% CI were calculated using log-log transformation.	From the time of first treatment up to Day 360
Secondary	Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Investigator's Rating on FWS	Investigator's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible [that is, visible furrows]), 2 (moderately strong muscle action possible [that is, visible muscle bulges]), 3 (strong muscle action possible which may cause local pallor). 95% CIs for percentage of participants were based on Pearson-clopper method.	At Day 180
Secondary	Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Participant's Rating on FWS	Participant's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for participant's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible [that is, visible furrows]), 2 (moderately strong muscle action possible [that is, visible muscle bulges]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method.	At Day 180
Secondary	Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Investigator's Rating on FWS	Investigator's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible [that is, visible furrows]), 2 (moderately strong muscle action possible [that is, visible muscle bulges]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method.	At Day 180
Secondary	Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Participant's Rating on FWS	Participant's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for participant's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible [that is, visible furrows]), 2 (moderately strong muscle action possible [that is, visible muscle bulges]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method.	At Day 180