Moderate to Severe Glabellar Frown LinesPhase 2NCT03806933
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
A Phase 2 study testing NT 201 in people with Moderate to Severe Glabellar Frown Lines, run by Merz Aesthetics GmbH at 9 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Glabellar Frown Lines
- What is being tested?
- NT 201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 23 Jan 2019to 8 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States5 sites
Clinical Testing of Beverly Hills, Merz Investigational Site #0010395
Encino, California, 91436
Tennessee Clinical Research Center, Merz Investigational Site #0010097
Nashville, Tennessee, 37215
Medical Associates Inc., Merz Investigational Site #0010435
Newport Beach, California, 92663
Cosmetic Laser Dermatology, Merz Investigational Site #0010321
San Diego, California, 92121
The Maas Clinics, Merz Investigational Site #0010338
San Francisco, California, 94115
Germany4 sites
Privatpraxis für Dermatologie und Ästhetische Medizin, Merz Investigational Site #0490306
Berlin, 10707
Universität Hamburg, Fachrichtung Kosmetik und Körperpflege, Merz Investigational Site #0490095
Hamburg, 20146
Dermatologische Gemeinschaftspraxis Dr. Prager und Partner, Merz Investigational Site #0490345
Hamburg, 22609
Skin & Laser Center, Merz Investigational Site #0490362
Potsdam, 14467
About this study
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
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).
Read the 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).
- Conditions
- Moderate to Severe Glabellar Frown Lines
- Being tested
- NT 201
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT 201Drug
Also called IncobotulinumtoxinA, Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% unpreserved Sodium Chloride (NaCl).
| Study group | Role | What they receive |
|---|---|---|
| NT 201 Dose group 1 | Experimental | Stage 1 and 2. Intramuscular injection into the glabellar area. Receives: Drug: NT 201 |
| NT 201 Dose group 2 | Experimental | Stage 1. Intramuscular injection into the glabellar area. Receives: Drug: NT 201 |
| NT 201 Dose group 3 | Experimental | Stage 1. Intramuscular injection into the glabellar area. Receives: Drug: NT 201 |
| NT 201 Dose group 4 | Experimental | Stage 2. Intramuscular injection into the glabellar area. Receives: Drug: NT 201 |
| NT 201 Dose group 5 | Experimental | Open Label Extension Period. Intramuscular injection into the glabellar area. Receives: Drug: NT 201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the time of first treatment up to Day 360
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Measured: From the time of first treatment up to Day 390
Number of Participants With at Least One Treatment-emergent Serious Adverse Event (TESAE)
Measured: 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)
Measured: From the time of first treatment up to Day 390
Number of Participants With at Least One Treatment Related TEAE
Measured: From the time of first treatment up to Day 390
Number of Participants With at Least One Treatment Related TESAE
Measured: From the time of first treatment up to Day 390
Secondary outcomes (6)
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.
Measured: 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
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.
Measured: 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
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.
Measured: At Day 180
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.
Measured: 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
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.
Measured: 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
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.
Measured: At Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start23 Jan 2019
- Primary completion10 Sep 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe Glabellar Frown LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Aesthetics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merz Pharmaceuticals GmbH
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806933
- Sponsor's protocol ID
- M602011015
- Other IDs
- 2018-002743-28, 2018
- Status last verified
- Nov 2023
- First submitted
- 15 Jan 2019
- Last updated
- 15 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34636520
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03806933
- Acronym / sponsor ID
- M602011015
- Conditions
- Moderate to Severe Glabellar Frown Lines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Merz Aesthetics GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Merz Pharmaceuticals GmbH
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Posted 4 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| NT 201 Dose group 1 | Experimental | Drug: NT 201Stage 1 and 2. Intramuscular injection into the glabellar area. |
| NT 201 Dose group 2 | Experimental | Drug: NT 201Stage 1. Intramuscular injection into the glabellar area. |
| NT 201 Dose group 3 | Experimental | Drug: NT 201Stage 1. Intramuscular injection into the glabellar area. |
| NT 201 Dose group 4 | Experimental | Drug: NT 201Stage 2. Intramuscular injection into the glabellar area. |
| NT 201 Dose group 5 | Experimental | Drug: NT 201Open Label Extension Period. Intramuscular injection into the glabellar area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT 201Also: IncobotulinumtoxinA, Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing proteinsClostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% unpreserved Sodium Chloride (NaCl). | Drug | NT 201 Dose group 1, NT 201 Dose group 2, NT 201 Dose group 3, NT 201 Dose group 4, NT 201 Dose group 5 |
Primary outcome
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.
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: 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
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
Number of Participants With at Least One Treatment Related TEAE
Time frame: 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
6 secondary outcomes
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 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
Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Investigator's Rating on FWS
Time frame: 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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34636520Kerscher 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merz Medical Expert study director
Merz Pharmaceuticals GmbH
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NT 201 in people with Moderate to Severe Glabellar Frown Lines, run by Merz Aesthetics GmbH at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03806933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.