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The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults and duration of effect.
This is a double-blind, randomized, parallel-group, controlled, dose-ranging, multi-center study to evaluate the safety and efficacy of RT001 compared to placebo applied as a single, bilateral application in at least 180 subjects with moderate to severe LCLs. Subjects will be randomized within each site to 1 of 3 treatment groups in a 1:1:1 ratio. The safety and efficacy of two different doses of RT001, compared to placebo, will be evaluated.
At least 180 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. Subjects will be enrolled in two (2) sequential cohorts. Cohort 1 will consist of 72 subjects; 24 subjects per treatment group. Cohort 2 will consist of 108 subjects; 36 subjects per treatment group. In order to confirm the safety of the test articles, Cohort 2 will not be enrolled until all Cohort 1 subjects have reached Day 14 or later with no Study Pause Criteria being observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose A | Active Comparator | Dose A RT001 |
|
| Dose B | Active Comparator | Dose B RT001 |
|
| Dose C | Placebo Comparator | Dose C Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RT001 | Drug | Dose A RT001 |
| |
| RT001 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to Day 28 | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debbie Tranowski | Revance Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin & Beauty Dermatology Center | Birmingham | Alabama | 35205 | United States | ||
| Richard G. Glogau, Inc. |
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| Drug |
Dose B RT001 |
|
| Placebo | Other | Dose C Placebo |
|
| San Francisco |
| California |
| 94117 |
| United States |
| Dermatology Research Institute, LLC | Coral Gables | Florida | 33146 | United States |
| SkinCare Physicians, Inc. | Chestnut Hill | Massachusetts | 02467 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| Head and Neck Surgical Group | New York | New York | 10019 | United States |
| Aesthetic Plastic Surgery | New York | New York | 10065 | United States |
| Dermatology Surgery and Laser Center | White Plains | New York | 10604 | United States |
| Suzanne Bruce & Associates / The Center for Skin Research | Houston | Texas | 77056 | United States |
| ID | Term |
|---|---|
| C000634027 | RT001 |
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