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

Glabellar Frown Lines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430586
• Other study ID #: MRZ 60201-0527/1
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2007
• Last updated: August 2, 2011
• Start date: November 2006
• Est. completion date: August 2007

Study information

• Verified date: August 2011
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate to severe glabellar frown lines

Exclusion Criteria:

• Previous insertion of permanent material in the glabellar area

• Neuromuscular function disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Drug:
• Botulinum neurotoxin type A, free of complexing proteins
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.
• Placebo
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.

Locations

Country	Name	City	State
Germany	Merz Pharmaceuticals GmbH	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Percentage of responders at maximum frown at Day 90 as assessed by the investigator according to FWS	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.	Baseline (Day 0) to Day 90	No
Secondary	Percentage of responders at maximum frown at Day 90 as assessed by patient's assessment	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.	Baseline (Day 0) to Day 90	No