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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.
This multi-center study evaluates the safety and efficacy of four different doses of RT001 compared to vehicle applied as a single, bilateral topical application in at least 60 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to one of the five treatment groups in a 1:1:1:1:1 ratio. Follow-up visits are scheduled through 28 days post-treatment. The safety and efficacy of Cohort 1 (through the Day 14 visit) will be assessed prior to the decision to enroll subjects into Cohort 2 if additional doses or treatment regimens need to be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose A | Active Comparator | RT001 Dose A; Active Comparator |
|
| Dose B | Active Comparator | RT001 Dose B; Active Comparator |
|
| Dose C | Active Comparator | RT001 Dose C; Active Comparator |
|
| Dose D | Active Comparator | RT001 Dose D; Active Comparator |
|
| Dose E | Placebo Comparator | RT001 Dose E; Vehicle Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RT001 | Drug | RT001 |
| |
| RT001 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Smile from Baseline (Day 0) to End of Study (Day 28) | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to End of Study (Day 28) | Day 28 | |
| Incidence of treatment-emergent AEs | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard G. Glogau, MD | San Francisco | California | 94117 | United States | ||
| Head and Neck Surgical Group |
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| ID | Term |
|---|---|
| C000634027 | RT001 |
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| Drug |
RT001 |
|
| RT001 | Drug | RT001 |
|
| RT001 | Drug | RT001 |
|
| Vehicle Comparator | Other | Vehicle Comparator |
|
| 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 |