Glabellar Lines Clinical Trial
| Verified date | February 2014 |
| Source | Allergan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study will evaluate the safety and efficacy of botulinum toxin type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides) for patients who successfully completed Study 191622-099.
| Status | Completed |
| Enrollment | 684 |
| Est. completion date | February 2012 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Successfully completed Study 191622-099 Exclusion Criteria: - Known immunization or hypersensitivity to botulinum toxin of any serotype - Anticipated need for treatment with botulinum toxin of any serotype during the study (except for study treatment) - Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis - Anticipated need for surgery or hospitalization during the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Allergan |
United States, Canada, France, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines | The investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported. | Day 30 | No |
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