NCT03806933

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2019

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

January 23, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2020

Completed
3 years until next milestone

Results Posted

Study results publicly available

October 4, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

January 15, 2019

Results QC Date

September 7, 2023

Last Update Submit

November 10, 2023

Conditions

Moderate to Severe Glabellar Frown Lines

Outcome Measures

Primary Outcomes (6)

  • 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

  • Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

    From the time of first treatment up to Day 390

  • Number of Participants With at Least One Treatment-emergent Serious Adverse Event (TESAE)

    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)

    From the time of first treatment up to Day 390

  • Number of Participants With at Least One Treatment Related TEAE

    From the time of first treatment up to Day 390

  • Number of Participants With at Least One Treatment Related TESAE

    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

    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

    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

    At Day 180

  • Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Participant's Rating on FWS

    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

    At Day 180

  • +1 more secondary outcomes

Study Arms (5)

NT 201 Dose group 1

EXPERIMENTAL

Stage 1 and 2. Intramuscular injection into the glabellar area.

Drug: NT 201

NT 201 Dose group 2

EXPERIMENTAL

Stage 1. Intramuscular injection into the glabellar area.

Drug: NT 201

NT 201 Dose group 3

EXPERIMENTAL

Stage 1. Intramuscular injection into the glabellar area.

Drug: NT 201

NT 201 Dose group 4

EXPERIMENTAL

Stage 2. Intramuscular injection into the glabellar area.

Drug: NT 201

NT 201 Dose group 5

EXPERIMENTAL

Open Label Extension Period. Intramuscular injection into the glabellar area.

Drug: NT 201

Interventions

NT 201DRUG

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

Also known as: IncobotulinumtoxinA, Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing proteins
NT 201 Dose group 1NT 201 Dose group 2NT 201 Dose group 3NT 201 Dose group 4NT 201 Dose group 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Clinical Testing of Beverly Hills, Merz Investigational Site #0010395

Encino, California, 91436, United States

Location

Medical Associates Inc., Merz Investigational Site #0010435

Newport Beach, California, 92663, United States

Location

Cosmetic Laser Dermatology, Merz Investigational Site #0010321

San Diego, California, 92121, United States

Location

The Maas Clinics, Merz Investigational Site #0010338

San Francisco, California, 94115, United States

Location

Tennessee Clinical Research Center, Merz Investigational Site #0010097

Nashville, Tennessee, 37215, United States

Location

Privatpraxis für Dermatologie und Ästhetische Medizin, Merz Investigational Site #0490306

Berlin, 10707, Germany

Location

Universität Hamburg, Fachrichtung Kosmetik und Körperpflege, Merz Investigational Site #0490095

Hamburg, 20146, Germany

Location

Dermatologische Gemeinschaftspraxis Dr. Prager und Partner, Merz Investigational Site #0490345

Hamburg, 22609, Germany

Location

Skin & Laser Center, Merz Investigational Site #0490362

Potsdam, 14467, Germany

Location

Related 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.

    PMID: 34636520BACKGROUND

MeSH Terms

Interventions

incobotulinumtoxinABotulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Results Point of Contact

Title
Public Disclosure Manager
Organization
Merz Pharmaceuticals GmbH
Aesthetic.Trials@merz.com
+49 69 1503 1

Study Officials

  • Merz Medical Expert

    Merz Pharmaceuticals GmbH

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 16, 2019

Study Start

January 23, 2019

Primary Completion

September 10, 2020

Study Completion

October 8, 2020

Last Updated

November 15, 2023

Results First Posted

October 4, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(4)US(5)