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

Conditions

• Glabellar Lines

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IncobotulinumtoxinA (Xeomin) (20 units) — DRUG
  Injection of a total of 20 Units incobotulinumtoxinA (Xeomin) on day one of each of up to eight cycles, reconstituted in a total injection volume of 0.5 mL administered in five equal parts of 0.1 mL to five predefined points of the glabellar area.

Study Details

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.

Key Dates

Start date

Jun 18, 2007

Status verified

Mar 2021

Primary completion

Dec 28, 2009

Completion

Dec 28, 2009

Study Design

Enrollment

801 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: IncobotulinumtoxinA (Xeomin) (20 units)
  IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection

Primary Outcome Measure

Incidence of Adverse Events (AEs) [ Time Frame: Baseline up to Month 30 ]

Locations (13)

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