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

November 10, 2023 updated by: Merz Aesthetics GmbH

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10707
        • Privatpraxis für Dermatologie und Ästhetische Medizin, Merz Investigational Site #0490306
      • Hamburg, Germany, 20146
        • Universität Hamburg, Fachrichtung Kosmetik und Körperpflege, Merz Investigational Site #0490095
      • Hamburg, Germany, 22609
        • Dermatologische Gemeinschaftspraxis Dr. Prager und Partner, Merz Investigational Site #0490345
      • Potsdam, Germany, 14467
        • Skin & Laser Center, Merz Investigational Site #0490362
  • United States
    • California
      • Encino, California, United States, 91436
        • Clinical Testing of Beverly Hills, Merz Investigational Site #0010395
      • Newport Beach, California, United States, 92663
        • Medical Associates Inc., Merz Investigational Site #0010435
      • San Diego, California, United States, 92121
        • Cosmetic Laser Dermatology, Merz Investigational Site #0010321
      • San Francisco, California, United States, 94115
        • The Maas Clinics, Merz Investigational Site #0010338
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center, Merz Investigational Site #0010097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NT 201 Dose group 1
Stage 1 and 2. Intramuscular injection into the glabellar area.
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).
Other Names:
  • Xeomin
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins
  • IncobotulinumtoxinA
Experimental: NT 201 Dose group 2
Stage 1. Intramuscular injection into the glabellar area.
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).
Other Names:
  • Xeomin
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins
  • IncobotulinumtoxinA
Experimental: NT 201 Dose group 3
Stage 1. Intramuscular injection into the glabellar area.
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).
Other Names:
  • Xeomin
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins
  • IncobotulinumtoxinA
Experimental: NT 201 Dose group 4
Stage 2. Intramuscular injection into the glabellar area.
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).
Other Names:
  • Xeomin
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins
  • IncobotulinumtoxinA
Experimental: NT 201 Dose group 5
Open Label Extension Period. Intramuscular injection into the glabellar area.
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).
Other Names:
  • Xeomin
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins
  • IncobotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Duration of Effect Defined as Time Between Treatment and Relapse to Baseline Status Assessed by the Investigator on the FWS
Time Frame: From the time of first treatment up to Day 360
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
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time Frame: From the time of first treatment up to Day 390
From the time of first treatment up to Day 390
Number of Participants With at Least One Treatment-emergent Serious Adverse Event (TESAE)
Time Frame: From the time of first treatment up to Day 390
From the time of first treatment up to Day 390
Number of Participants With at Least One Treatment-emergent Adverse Event of Special Interest (TEAESI)
Time Frame: From the time of first treatment up to Day 390
From the time of first treatment up to Day 390
Number of Participants With at Least One Treatment Related TEAE
Time Frame: From the time of first treatment up to Day 390
From the time of first treatment up to Day 390
Number of Participants With at Least One Treatment Related TESAE
Time Frame: From the time of first treatment up to Day 390
From the time of first treatment up to Day 390

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: From the time of first treatment up to Day 360
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
Duration of Effect Whereby Effect Was Defined by 2-point Improvement From Baseline at Maximum Frown as Assessed by the Investigator According to FWS
Time Frame: From the time of first treatment up to Day 360
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
Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Investigator's Rating on FWS
Time Frame: At Day 180
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
Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Participant's Rating on FWS
Time Frame: At Day 180
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
Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Investigator's Rating on FWS
Time Frame: At Day 180
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
Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Participant's Rating on FWS
Time Frame: At Day 180
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merz Aesthetics GmbH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merz Pharmaceuticals GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Merz Medical Expert, Merz Pharmaceuticals GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M602011015
  • 2018-002743-28 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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