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

This study has been completed.
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00430586
First received: February 1, 2007
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Glabellar Frown Lines
Drug: Botulinum neurotoxin type A, free of complexing proteins
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS) [ Time Frame: Baseline (Day 0) to Day 30 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline (Day 0) to Day 30 ] [ Designated as safety issue: No ]

    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:
  • Percentage of responders at maximum frown at Day 90 as assessed by the investigator according to FWS [ Time Frame: Baseline (Day 0) to Day 90 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline (Day 0) to Day 90 ] [ Designated as safety issue: No ]

    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.



Enrollment: 191
Study Start Date: November 2006
Study Completion Date: August 2007
Arms Assigned Interventions
Experimental: 20 U NT 201 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.
Other Names:
  • BTX-A,
  • BoNT/A,
  • incobotulinumtoxinA (Xeomin)
Placebo Comparator: Placebo Drug: 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.
Experimental: 10 U NT 201 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.
Other Names:
  • BTX-A,
  • BoNT/A,
  • incobotulinumtoxinA (Xeomin)
Experimental: 30 U NT 201 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.
Other Names:
  • BTX-A,
  • BoNT/A,
  • incobotulinumtoxinA (Xeomin)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe glabellar frown lines

Exclusion Criteria:

  • Previous insertion of permanent material in the glabellar area
  • Neuromuscular function disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430586

Locations
Germany
Merz Pharmaceuticals GmbH
Frankfurt, Germany, 60318
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Study Chair: Merz Pharmaceuticals Merz Pharmaceuticals GmbH
  More Information

No publications provided

Responsible Party: Public Disclosure Manager, Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00430586     History of Changes
Other Study ID Numbers: MRZ 60201-0527/1
Study First Received: February 1, 2007
Last Updated: August 2, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014