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

Merz Aesthetics GmbH241 enrolled

Overview

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).

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

241

Conditions

Moderate to Severe Glabellar Frown Lines

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

Clinical Testing of Beverly Hills, Merz Investigational Site #0010395

Encino, California, 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

Outcomes

Primary Outcomes

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.

Time frame: From the time of first treatment up to Day 360

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