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This research is being done to determine if lower doses of botox than what is currently recommended can give similar results to patients, at lower cost and lower risk to them. Subjects will receive botox in the same areas of the upper face with standard doses on one side of the face. On the other side, double the botox concentration will be administered, free of charge to the participant, in order to see if the difference in concentration creates a difference in wrinkle reduction and participant satisfaction over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Dosing Group | Active Comparator |
| |
| Half Standard Dosing Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA Standard Dose | Drug | Active comparator group will be treated for full upper face wrinkles with standard recommended doing of onabotulinumtoxinA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Upper Face Wrinkle Severity 1 Week After Botox Administration | The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months. | 4 Months |
| Upper Face Wrinkle Severity 1 Month After Botox Administration | The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months. | 4 Months |
| Upper Face Wrinkle Severity 2 Months After Botox Administration | The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months. | 4 Months |
| Upper Face Wrinkle Severity 3 Months After Botox Administration | The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months. | 4 Months |
| Upper Face Wrinkle Severity 4 Months After Botox Administration | The severity of upper face wrinkles will be assessed on a 0 - 4 scale by a trained observer in both relaxed and expressive states. Efficacy will be assessed at 1 week, 1 month, 2 months, 3 months, and 4 months. | 4 Months |
| Patient Satisfaction 1 Week After Botox Administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Bastidas, MD | Northwell Health | Principal Investigator |
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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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| OnabotulinumtoxinA Half Standard Dose | Drug | Experimental group will be treated for full upper face wrinkles with half of the standard recommended doing of onabotulinumtoxinA |
|
A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration
| 4 Months |
| Patient Satisfaction 1 Month After Botox Administration | A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration | 4 Months |
| Patient Satisfaction 2 Months After Botox Administration | A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration | 4 Months |
| Patient Satisfaction 3 Months After Botox Administration | A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration | 4 Months |
| Patient Satisfaction 4 Months After Botox Administration | A satisfaction survey (on a scale of 0-10) will be administered to the participant at 1 week, 1 month, 2 months, 3 months and 4 months from the date of botox administration | 4 Months |
| 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 |