An interventional study of OnabotulinumtoxinA Standard Dose and OnabotulinumtoxinA Half Standard Dose in Rhytides, sponsored by Northwell Health. Withdrawn. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-16.
Sponsored by Northwell Health · Not applicable, Interventional, and Other
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.
Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.
Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: OnabotulinumtoxinA Standard Dose
Drug: OnabotulinumtoxinA Half Standard Dose
Active comparator group will be treated for full upper face wrinkles with standard recommended doing of onabotulinumtoxinA
Experimental group will be treated for full upper face wrinkles with half of the standard recommended doing of onabotulinumtoxinA
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 Months
Patient Satisfaction 1 Week 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4 Months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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