Rhytides
Conditions
Keywords
Botox, Facial Wrinkles, OnabotulinumtoxinA, Cosmetic, Dosage
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.
Interventions
DRUGOnabotulinumtoxinA Standard Dose
Active comparator group will be treated for full upper face wrinkles with standard recommended doing of onabotulinumtoxinA
DRUGOnabotulinumtoxinA Half Standard Dose
Experimental group will be treated for full upper face wrinkles with half of the standard recommended doing of onabotulinumtoxinA
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper Face Wrinkle Severity 1 Week After Botox Administration | 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 1 Month After Botox Administration | 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 2 Months After Botox Administration | 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 | 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 4 Months After Botox Administration | 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 | 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 1 Month After Botox Administration | 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 | 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 3 Months After Botox Administration | 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 | 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 |
Outcome results
None listed