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Neurotoxin

Botulinum Toxins for Forehead Wrinkles

Phase < 1
Waitlist Available
Research Sponsored by Lupo Center for Aesthetic and General Dermatology
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 14 days post-treatment
Awards & highlights

Study Summary

This trial studies how 2 wrinkle-relaxing treatments compare when injected into the forehead. 10 people will be part of the trial.

Who is the study for?
This trial is for adults aged 18-65 with moderate-to-severe dynamic forehead wrinkles and minimal static lines, in good health, and not pregnant. They must have no recent botulinum toxin treatments or facial fillers, no substance abuse history, no neuromuscular disorders, and be willing to follow the study protocol.Check my eligibility
What is being tested?
The study compares PrabotulinumtoxinA-xvfs versus OnabotulinumtoxinA on either side of the forehead in 10 subjects to see which better reduces wrinkles. The effectiveness will be evaluated at two weeks post-injection by examining wrinkle diminution.See study design
What are the potential side effects?
Possible side effects include localized pain, infection at the injection site, inflammation, swelling or bruising around the area injected; headache; flu-like symptoms; droopy eyelids or eyebrows if spread occurs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Surface area of rhytid diminution
Secondary outcome measures
5-point photonumeric scale for resting or static and hyperkinetic or dynamic horizontal forehead lines
Adverse events

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental halfExperimental Treatment1 Intervention
Each subject will be randomized to have either their right forehead or left forehead treated with 4 units or 0.1 cc of prabotulinumtoxinA 2.5 cm above the orbital rim.
Group II: Comparator halfActive Control1 Intervention
Each subject will be randomized to have either their right forehead or left forehead treated with 4 units or 0.1 cc of onabotulinumtoxinA 2.5 cm above the orbital rim.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PrabotulinumtoxinA-Xvfs
2023
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

Lupo Center for Aesthetic and General DermatologyLead Sponsor
Evolus, Inc.Industry Sponsor
7 Previous Clinical Trials
2,509 Total Patients Enrolled

Frequently Asked Questions

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

Is this research endeavor recruiting participants who are older than 25?

"In order to participate in this medical trial, patients must be between 18 and 65 years of age."

Answered by AI

Is my profile suitable for enrolment in this research experiment?

"Eligibility criteria for this trial is limited to individuals aged 18 and 65 who possess wrinkles. This clinical study has a total capacity of 10 participants."

Answered by AI

Are there any open slots for prospective participants in this trial?

"This medical experiment is searching for participants, as visible on clinicaltrials.gov. The trial was initially made public on May 1st 2023 and the latest update was issued October 2nd of that same year."

Answered by AI

What is the scale of this experiment in terms of participant numbers?

"Affirmative. The details found on clinicaltrials.gov indicate that this medical research is actively seeking participants, having been posted May 1st 2023 and recently updated October 2nd of the same year. 10 individuals are required at a single trial site."

Answered by AI

Who else is applying?

What site did they apply to?
Lupo Center for Aesthetic and General Dermatology
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

I have had botox and fillers on my face but it has been over 4 years ago.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Spread of PrabotulinumtoxinA-xvfs Versus OnabotulinumtoxinA in the Treatment of Forehead Rhytides
2023. "Spread of PrabotulinumtoxinA-xvfs Versus OnabotulinumtoxinA in the Treatment of Forehead Rhytides". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05807412.
~5 spots leftby Apr 2025
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