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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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~120 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Injection of onabotulinumtoxinA, 2 mm depth
Injection of onabotulinumtoxinA, 4 mm depth
Secondary outcome measures
Efficacy comparison
Measure

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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,979 Total Patients Enrolled
David Ozog, MDPrincipal InvestigatorHenry Ford Health
4 Previous Clinical Trials
64 Total Patients Enrolled

Media Library

onabotulinumtoxinA (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05766683 — Phase 1
Frown Lines Research Study Groups: 2mm depth, 4mm depth
Frown Lines Clinical Trial 2023: onabotulinumtoxinA Highlights & Side Effects. Trial Name: NCT05766683 — Phase 1
onabotulinumtoxinA (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05766683 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is 2mm depth accepted according to FDA regulations?

"The available data indicates that 2mm depth is safe, thus it was scored a 1 on our scale. This score reflects the fact this Phase 1 trial has only limited evidence demonstrating both safety and efficacy."

Answered by AI

Would it be possible to sign up for this research project presently?

"Per the data hosted on clinicaltrials.gov, this specific medical trial is not presently looking for patients to participate. Initially posted on March 14th 2023 and last updated on 23rd of that same month, although no longer enrolling participants, 8 other studies are actively recruiting individuals right now."

Answered by AI

Who else is applying?

What site did they apply to?
Henry Ford Health System
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Reduction in face wrinkles.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Depth of Botulinum Neurotoxin Injection for Treatment of Glabellar Lines
David M. Ozog 2023. "Depth of Botulinum Neurotoxin Injection for Treatment of Glabellar Lines". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05766683.
~10 spots leftby Apr 2025
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