Phase 3 N=801 Treatment

Safety and Efficacy of NT 201 (IncobotulinumtoxinA [Xeomin]) in the Treatment of Glabellar Frown Lines

Glabellar Lines

Bottom Line

View on ClinicalTrials.gov: NCT00512135 ↗

Enrolled (actual)

801

Serious AEs

3.6%

Results posted

Apr 2021

Primary outcome: Primary: Incidence of Adverse Events (AEs) — 374 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: IncobotulinumtoxinA (Xeomin) (20 units) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merz Pharmaceuticals GmbH
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Adverse Events (AEs)	374	—
PRIMARY Incidence of Adverse Events of Special Interest (AESI)	9	—
PRIMARY Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS)	79.1; 79.8; 80.1; 80.3; 81.4; 81.2	—
PRIMARY Percentage of Responders at Rest as Assessed by the Investigator According to FWS	78.9; 79.7; 80.7; 80.6; 79.4; 77.0	—
PRIMARY Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale	86.2; 87.6; 88.2; 87.4; 85.9; 88.5	—
PRIMARY Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale	69.5; 67.0; 73.0; 73.8; 77.0; 75.1	—
PRIMARY Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown	118; 256; 210; 140; 46; 16	—
PRIMARY Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest	237; 281; 144; 89; 28; 7	—
PRIMARY Time to Onset of Treatment Effect	15; 10; 86; 168; 171; 93	—

Summary

The study objective was to investigate the safety and efficacy of incobotulinumtoxinA (Xeomin) during repeat dose treatment of glabellar frown lines. 801 participants with moderate to severe glabellar frown lines at maximum frown who completed participation in one of the studies in this program, i.e. MRZ 60201-0520/1, MRZ 60201-0527/1, MRZ 60201-0724/1, or MRZ 60201-0741/1 were eligible to participate in this repeat-dose study.

Eligibility Criteria

Inclusion Criteria

Participants with 'moderate' or 'severe' glabellar frown lines at maximum frown at the beginning of each treatment cycle (as assessed by the investigator according to FWS) , stable medical condition; Completion of one former study in the Merz NT 201 glabellar program

Exclusion Criteria

Participants with preexisting neuromuscular diseases (e.g. myasthenia gravis, Lambert-Eaton syndrome) putting the participant at risk, History of Facial Nerve Palsy, Previous treatment with Botulinum Toxin in the glabellar area during the last 12 months, Previous treatment with biodegradable fillers or other procedures (e.g. chemical peeling, photo rejuvenation) in the glabellar area during the last 12 months, Previous insertion of permanent material in the glabellar area; Planned treatment with Botulinum toxin of any serotype in any body region during the study period, Any other planned facial aesthetic procedure in the glabellar area during the trial period; Any surgery in the glabellar area including surgical removal of the corrugator, procerus or depressor supercili muscles or a combination of these or scars in the glabellar area, Inability to substantially lessen glabellar frown lines even by physically spreading apart, Marked facial asymmetry or ptosis of eyelid and/or eyebrow; Any infection in the area of the injection sites.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00512135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.