Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines
A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Determine the Optimal Dose of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
1 other identifier
interventional
191
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2006
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 1, 2007
CompletedFirst Posted
Study publicly available on registry
February 2, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedAugust 3, 2011
August 1, 2011
February 1, 2007
August 2, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS)
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.
Baseline (Day 0) to Day 30
Percentage of responders at maximum frown at Day 30 as assessed by patient's assessment according to 4-point scale
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.
Baseline (Day 0) to Day 30
Secondary Outcomes (2)
Percentage of responders at maximum frown at Day 90 as assessed by the investigator according to FWS
Baseline (Day 0) to Day 90
Percentage of responders at maximum frown at Day 90 as assessed by patient's assessment
Baseline (Day 0) to Day 90
Study Arms (4)
20 U NT 201
EXPERIMENTALPlacebo
PLACEBO COMPARATOR10 U NT 201
EXPERIMENTAL30 U NT 201
EXPERIMENTALInterventions
Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group. The total dose volume was administered in equal aliquots to the 5 injection sites. Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site.
Single treatment with Placebo given as intramuscular treatment injections of equal amount to 5 sites on Day 0. A volume of reconstituted 0.6 mL per subject was administered. The total dose volume was administered in equal aliquots to the 5 injection sites. Thus, each of the 5 injection sites was injected with 0.12 mL Placebo per injection site.
Eligibility Criteria
You may qualify if:
- Moderate to severe glabellar frown lines
You may not qualify if:
- Previous insertion of permanent material in the glabellar area
- Neuromuscular function disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Merz Pharmaceuticals GmbH
Frankfurt, 60318, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Merz Pharmaceuticals
Merz Pharmaceuticals GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 1, 2007
First Posted
February 2, 2007
Study Start
November 1, 2006
Study Completion
August 1, 2007
Last Updated
August 3, 2011
Record last verified: 2011-08