Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles (NCT04994990) | Clinical Trial Compass
WithdrawnNot Applicable
Effective OnabotulinumtoxinA Dose Response Study for Upper Facial Wrinkles
Stopped: staff not available to support study
0Started 2023-05-25
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Upper Face Wrinkle Severity 1 Week After Botox Administration
Timeframe: 4 Months
2
Upper Face Wrinkle Severity 1 Month After Botox Administration
Timeframe: 4 Months
3
Upper Face Wrinkle Severity 2 Months After Botox Administration
Timeframe: 4 Months
4
Upper Face Wrinkle Severity 3 Months After Botox Administration
Timeframe: 4 Months
5
Upper Face Wrinkle Severity 4 Months After Botox Administration
Timeframe: 4 Months
6
Patient Satisfaction 1 Week After Botox Administration
Timeframe: 4 Months
7
Patient Satisfaction 1 Month After Botox Administration