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The purpose of this study is to determine the safety and efficacy of 2 sequential doses of RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.
This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the safety and efficacy of repeat application of RT001 in at least 30 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (RT001 Dose A or vehicle control).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | RT001 (Botulinum Toxin Type A Topical Gel) |
|
| 2 | Placebo Comparator | Vehicle Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vehicle Control | Other | Two sequential doses of Vehicle Control at Baseline (Day 0) and Week 2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects classified as exhibiting improvement via the Investigator Global Assessment from Baseline (Day 0) to End of Study (Week 6). | Baseline (Day 0) and Week 6 | |
| Incidence of treatment emergent AEs. | Baseline (Day 0) and Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Bruce, MD | The Center for Skin Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suzanne Bruce & Associates / The Center for Skin Research | Houston | Texas | 77056 | United States |
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| ID | Term |
|---|---|
| C000634027 | RT001 |
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| RT001 (Botulinum Toxin Type A Topical Gel) |
| Drug |
Two sequential doses of RT001 at Baseline (Day 0) and Week 2 |
|