Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines

Phase 2

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Drug: Botulinum neurotoxin type A, free of complexing proteins; Drug: Placebo

• Registration Number: NCT00430586
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

NT 201 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, NT 201 causes local weakening to full paralysis depending on the administered dose. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study will determine the optimal dose of NT 201 in the treatment of glabellar frown lines.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-02-01
• Study First Submitted QC: 2007-02-01
• Study First Posted: 2007-02-02
• Study Completion: 2007-08
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-02
• Last Update Posted: 2011-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

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
20 U NT 201	Botulinum neurotoxin type A, free of complexing proteins	-
Placebo	Placebo	-
10 U NT 201	Botulinum neurotoxin type A, free of complexing proteins	-
30 U NT 201	Botulinum neurotoxin type A, free of complexing proteins	-

Primary Outcome Measures

Name	Time	Method
Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS)	Baseline (Day 0) to Day 30	Responders on the FWS are defined as subjects with glabellar line severity of none (0) or mild (1).; The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints.
Percentage of responders at maximum frown at Day 30 as assessed by patient's assessment according to 4-point scale	Baseline (Day 0) to Day 30	Responders will be subjects with at least a 1-point improvement compared to Day 0.; The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints.

Secondary Outcome Measures

Name	Time	Method
Percentage of responders at maximum frown at Day 90 as assessed by the investigator according to FWS	Baseline (Day 0) to Day 90	Responders on the FWS are defined as subjects with glabellar line severity of none (0) or mild (1).; Secondary efficacy endpoints will be analyzed analogously to the analysis of primary efficacy endpoint.
Percentage of responders at maximum frown at Day 90 as assessed by patient's assessment	Baseline (Day 0) to Day 90	Responders will be subjects with at least a 1-point improvement compared to Day 0.; Secondary efficacy endpoints will be analyzed analogously to the analysis of primary efficacy endpoint.

Trial Locations

Locations (1)

Merz Pharmaceuticals GmbH; 🇩🇪 Frankfurt, Germany