Glabellar Lines Clinical Trial
Official title:
A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of NEURONOX® vs. BOTOX® in Patients With Moderate to Severe Glabellar Lines
| Verified date | July 2017 |
| Source | Medy-Tox |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with moderate to severe glabellar lines.
| Status | Completed |
| Enrollment | 504 |
| Est. completion date | March 7, 2017 |
| Est. primary completion date | November 10, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Subjects aged between 18 and 65 - Subjects with more than grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum frown Exclusion Criteria: - Subjects with medical conditions who may be greater risk due to the administration of the investigational drugs - Subjects with skin disorders at the injection site |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Medy-Tox |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 4-grade scale by live assessment of glabellar line severity | Glabellar line improvement rate at maximum frown | 4 weeks after injection |
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