Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles

Study Overview
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Brief Summary
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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.

Official Title
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Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles

Conditions
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Rhytides

Intervention / Treatment
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* Drug: OnabotulinumtoxinA Standard Dose
* Drug: OnabotulinumtoxinA Half Standard Dose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Dosing Group<br> | Drug: OnabotulinumtoxinA Standard Dose<br>* Active comparator group will be treated for full upper face wrinkles with standard recommended doing of onabotulinumtoxinA<br>|
| Experimental: Half Standard Dosing Group<br> | Drug: OnabotulinumtoxinA Half Standard Dose<br>* Experimental group will be treated for full upper face wrinkles with half of the standard recommended doing of onabotulinumtoxinA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botox, Facial Wrinkles, OnabotulinumtoxinA, Cosmetic, Dosage