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Neuromodulator

DaxibotulinumtoxinA 20 units for Aging

Phase 4

Recruiting

Led By Kachiu Lee, MD

Research Sponsored by Main Line Center for Laser Surgery

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

>30 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial aims to assess how well and for how long DaxibotulinumtoxinA works for making the neck look younger by treating platysmal bands. Participants will receive one treatment and

Who is the study for?

This trial is for individuals over 30 years old who want to improve the appearance of their neck by reducing platysmal bands, which are signs of aging. Participants must have a moderate to severe rating on the Merz Neck Scale and haven't used any botulinum toxin in their neck for at least six months. Pregnant individuals or those with certain medical conditions like connective tissue disorders, neuromuscular issues, or active infections in the treatment area cannot join.Check my eligibility

What is being tested?

The study tests DaxibotulinumtoxinA's effectiveness in rejuvenating the neck by treating platysmal bands. Participants will be randomly assigned to receive either 15 or 20 units per band during one treatment visit and will return for follow-ups over a period of up to 24 weeks.See study design

What are the potential side effects?

Potential side effects may include localized pain, swelling, bruising at injection sites, muscle weakness near treated areas, difficulty swallowing (dysphagia), headache, allergic reactions such as itching or rash. These are common risks associated with botulinum toxin treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 30 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effectiveness of DaxibotulinumtoxinA for platysmal neck bands measured on Platysmal Neck Banding Scale

Secondary outcome measures

Evaluate patient-reported outcomes (patient satisfaction with neck using FACE-Q scale)

Trial Design

2Treatment groups

Experimental Treatment

Group I: DaxibotulinumtoxinA 20 unitsExperimental Treatment1 Intervention

Subjects will receive 20 units of daxibotulinumtoxinA per platysmal band, up to 2 anterior bands and 2 lateral bands.

Group II: DaxibotulinumtoxinA 15 unitsExperimental Treatment1 Intervention

Subjects will receive 15 units of daxibotulinumtoxinA per platysmal band, up to 2 anterior bands and 2 lateral bands.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Main Line Center for Laser SurgeryLead Sponsor

3 Previous Clinical Trials

62 Total Patients Enrolled

1 Trials studying Aging

20 Patients Enrolled for Aging

Kachiu Lee, MDPrincipal InvestigatorPhysician

2 Previous Clinical Trials

42 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available positions for participants in this research study?

"Indeed, as stated on clinicaltrials.gov, this ongoing research study is actively seeking eligible participants. The trial was first listed on January 1st, 2024 and recently updated on January 24th, 2024."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical trial?

"Indeed, according to the information available on clinicaltrials.gov, this trial is actively seeking participants. It was initially published on January 1st, 2024 and recently updated on January 24th, 2024. The study aims to recruit a total of 20 patients from a single site."

Answered by AI

Has the FDA authorized the usage of DaxibotulinumtoxinA in 20 unit doses?

"Our team at Power has assigned a safety rating of 3 to DaxibotulinumtoxinA 20 units, as this is a Phase 4 trial indicating that the treatment has already received approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DaxibotulinimtoxinA for Treatment of Platysmal Neck Bands

Kachiu Lee, MD 2024. "DaxibotulinimtoxinA for Treatment of Platysmal Neck Bands". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06225492.