IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines

Phase 3

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Drug: Placebo; Drug: IncobotulinumtoxinA (Xeomin) (20 Units)

• Registration Number: NCT00430963
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, IncobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study investigated the efficacy and safety of IncobotulinumtoxinA (Xeomin) in the treatment of glabellar frown lines compared to placebo. The study consisted of a Main Period and an Open-Label Extension \[OLEX\] Period of 120 days each.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-02-01
• Study First Submitted QC: 2007-02-01
• Study First Posted: 2007-02-02
• Primary Completion: 2007-04
• Study Completion: 2007-11
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-25
• Last Update Posted: 2011-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

•Moderate to severe glabellar frown lines

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Exclusion Criteria

• Previous insertion of permanent material in the glabellar area
• Neuromuscular function disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding to total placebo volume 0.5 mL; mode of administration: intramuscular injection
IncobotulinumtoxinA (Xeomin) (20 Units)	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 Measures

Name	Time	Method
Investigator's assessment according to the Facial Wrinkle Scale (FWS)	Day 30	Responder: FWS score of 0 or 1.
Patient's global assessment	Day 30	Responder: subjects with a score of at least 2+.

Secondary Outcome Measures

Name	Time	Method
Investigator's assessment according to FWS	Day 7, 60, 90, and 120	Responder: FWS score of 0 or 1.
Patient's global assessment	Day 7, 60, 90, and 120	Responder: subjects with a score of at least 2+.

Trial Locations

Locations (1)

Merz Pharmaceuticals GmbH; 🇩🇪 Frankfurt, Germany