Glabellar Frown Lines
Conditions
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.
Interventions
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.
DRUGPlacebo
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.
Sponsors
Merz Pharmaceuticals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed