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The purpose of this study is to find out if an investigational drug, called RT001 Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called lateral canthal lines, also known as crow's feet wrinkles.
RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001 is more effective than three comparator groups by examining the effect on the improvement of crow's feet by both the patient and physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT001 Botulinum toxin Type A (Dose A) | Experimental | RT001 (Botulinum toxin Type A) |
|
| RT001 Botulinum toxin type A (Dose B) | Experimental | RT001 (Botulinum Toxin Type A) |
|
| Dose C | Other | Vehicle Control |
|
| Dose D | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RT001 Botulinum toxin type A (Dose A) | Drug | RT001 Botulinum Toxin Type A (Dose A) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject improvement based in investigator assessment | The number of subjects who show improvement based on the investigator global assessment | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Improvement Based on investigator and patient assessments | The number of subjects who show improvement based on the investigator global and patient assessments | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Research Institute, LLC | Coral Gables | Florida | 33146 | United States |
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| RT001 Botulinum Toxin Type A (Dose B) | Drug | RT001 Botulinum Toxin Type A (Dose B) |
|
| Vehicle | Other | Vehicle Control |
|
| Placebo | Drug | Placebo Comparator |
|