Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Northwell Health
- Primary Endpoint
- Upper Face Wrinkle Severity 4 Months After Botox Administration
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18-65
- •In good general health as evidenced by medical history and exhibiting upper facial wrinkles on physical examination
- •Agreement to adhere to Lifestyle Considerations (see section 5.3) as appropriate throughout study duration
Exclusion Criteria
- •Current use of aminoglycosides, curare like agents, and muscle relaxants
- •Pregnancy or lactation
- •Known allergic reactions to components of the botox formulation and any of its ingredients
- •Treatment with another botox product for the face within 4 months
- •Infections/preexisting weakness at the proposed injection sites on physical examination
- •History of neuromuscular disorder, pre existing severe cardiovascular disease, compromised respiratory function, severe dysphagia
- •Pediatric population, patients older than 65 since the effect of botox in terms of duration and magnitude is highly variable in these age groups.
Arms & Interventions
Standard Dosing Group
Intervention: OnabotulinumtoxinA Standard Dose (Drug)
Half Standard Dosing Group
Intervention: OnabotulinumtoxinA Half Standard Dose (Drug)
Outcomes
Primary Outcomes
Upper Face Wrinkle Severity 4 Months After Botox Administration
Time Frame: 4 Months
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.
Patient Satisfaction 1 Month After Botox Administration
Time Frame: 4 Months
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
Patient Satisfaction 2 Months After Botox Administration
Time Frame: 4 Months
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
Upper Face Wrinkle Severity 1 Week After Botox Administration
Time Frame: 4 Months
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.
Upper Face Wrinkle Severity 3 Months After Botox Administration
Time Frame: 4 Months
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.
Patient Satisfaction 1 Week After Botox Administration
Time Frame: 4 Months
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
Upper Face Wrinkle Severity 1 Month After Botox Administration
Time Frame: 4 Months
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.
Patient Satisfaction 3 Months After Botox Administration
Time Frame: 4 Months
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
Patient Satisfaction 4 Months After Botox Administration
Time Frame: 4 Months
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
Upper Face Wrinkle Severity 2 Months After Botox Administration
Time Frame: 4 Months
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.
Secondary Outcomes
No secondary outcomes reported