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Neurotoxin
Botulinum Neurotoxin Injection at Different Depths for Frown Lines
Phase 1
Waitlist Available
Led By David Ozog, MD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will determine if the depth of onabotulinumtoxinA neurotoxin injection affects its efficacy and safety in treating glabellar frown lines.
Who is the study for?
This trial is for adults over 18 who have frown lines and want to try Botulinum toxin therapy. Participants must understand the study's requirements and risks, and be able to give informed consent.
What is being tested?
The trial tests whether injecting onabotulinumtoxinA at different depths (2mm vs 4mm) in the forehead area affects how well it improves frown lines. The main goal is to find out which depth gives better results with fewer side effects.
What are the potential side effects?
Potential side effects of onabotulinumtoxinA injections can include pain at the injection site, headache, temporary facial drooping or asymmetry, muscle weakness near where the medicine was injected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 120 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Injection of onabotulinumtoxinA, 2 mm depth
Injection of onabotulinumtoxinA, 4 mm depth
Secondary study objectives
Efficacy comparison
Measure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: 4mm depthExperimental Treatment1 Intervention
Subjects will be randomized using computer generated randomization list provided by PHS to receive onabotulinumtoxinA neurotoxin injections in the glabellar complex at depth of 4mm
Group II: 2mm depthExperimental Treatment1 Intervention
Subjects will be randomized using computer generated randomization list provided by PHS to receive onabotulinumtoxinA neurotoxin injections in the glabellar complex at depth of 2mm
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Henry Ford Health SystemLead Sponsor
311 Previous Clinical Trials
2,176,346 Total Patients Enrolled
David Ozog, MDPrincipal InvestigatorHenry Ford Health
4 Previous Clinical Trials
64 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had facial surgery or scars that could affect the study's outcome.I have a history of neuromuscular disorders like myasthenia gravis.I am 18 years old or older.I understand what participating in the study involves and its risks.I have not had botulinum toxin treatments on my face in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: 2mm depth
- Group 2: 4mm depth
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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