Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a single treatment of three different doses of botulinum toxin compared to placebo, in the treatment of moderate to very severe glabellar frown lines.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin 30 units | Experimental | I.M. injection |
|
| Botulinum Toxin 45 units | Experimental | I.M. injection |
|
| Botulinum Toxin 60 units | Experimental | I.M. injection |
|
| Placebo | Placebo Comparator | I.M. injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin | Reduction in glabellar frown line severity is derived separately for the Investigator and the subject assessment, using a validated photo scale, at maximum frown on Day 14. | 14 Days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private practice | Birmingham | Alabama | United States | |||
| Private practice |
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
|
| Mobile |
| Alabama |
| United States |
| Private practice | San Diego | California | United States |
| Private practice | Englewood | Colorado | United States |
| Private practice | Aventura | Florida | United States |
| Private practice | Nashville | Tennessee | United States |
| Private practice | San Antonio | Texas | United States |
| Private practice | Salt Lake City | Utah | United States |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |