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The purpose of this study is to find out if an investigational drug, called RT001 Botulinum Toxin Type A Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called crow's feet, also known as lateral canthal lines.
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 RT001is more effective than placebo gel 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 |
|---|---|---|---|
| Dose A | Active Comparator | RT001 Topical Gel |
|
| Dose B | Placebo Comparator | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Drug | RT001 (Botulinum Toxin Type A Topical Gel, Dose A) applied topically at Baseline (Day 0) to the lateral canthal lines |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects who show improvement based on the investigator global and patient assessments. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects who show improvement based on the investigator global and patient assessments. | Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fredric Brandt, MD | Dermatology Research Institute, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Research Institute, LLC | Coral Gables | Florida | 33146 | United States |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Placebo (Dose B) | Drug | Placebo (Dose B), applied topically at Baseline (Day 0) to the lateral canthal lines |
|
| 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 |