Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines
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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 |
- 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.
- 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:
|
| 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:
|
| 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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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 Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013