NCT06225492

DaxibotulinimtoxinA for Treatment of Platysmal Neck Bands

Use of DaxibotulinimtoxinA Injection for Platysma Bands of the Neck

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Main Line Center for Laser Surgery · Academic / Other
• Sex: All
• Age: 31 Years
• Healthy volunteers: Accepted

Summary

This study seeks to evaluate the effectiveness and duration of action of DaxibotulinumtoxinA for neck rejuvenation through treatment of platysmal bands. This study will consist of one treatment visit with subjects being randomized to receiving 15 or 20 units of DaxibotulinumtoxinA per platysmal band. Subjects will return for 5 follow-up visits at 8, 12, 16, 20, and 24 weeks for evaluation.

Detailed description

This clinical investigation is a prospective study consisting of a screening/treatment visit and 5 follow-up visits. A total of 20 patients will be recruited. Following informed consent and screening, each eligible subject will be photographed. Next, patients will be randomized to receive 15 or 20 units of DaxibotulinumtoxinA per platysmal band. Patients randomized to each group will receive the same dosage injected to each neck band divided over 4 to 5 injection sites (up to 2 anterior and 2 lateral platysmal bands). After randomization, patients will be treated with either 15 or 20 units per band. After treatment, subjects will be provided with post treatment instructions. Randomization will be conducted by having the patient pick either "15" or "20" out of a box. A total of 10 patients will be randomized to the 15 unit/platysmal band group. Another 10 patients will be randomized to the 20 unit/platysmal band group. The physician will fill out the 5-point Merz Neck Scale at baseline and at each follow-up visit. Photographs will be captured at each visit. The patient will return at post-treatment weeks 8, 12, 16, 20, and 24. Subjects will fill out FACE-Q Satisfaction with Outcome surveys at each follow-up visit. FACE-Q Appraisal of Neck surveys will be filled out by the patient at the baseline and follow-up visits. A blinded independent evaluator will evaluate the baseline and post-treatment photographs on Merz Neck Scale after completion of the study.

Conditions

• Aging

Interventions

Type	Name	Description
DRUG	DaxibotulinumtoxinA 15 units	Subjects will be treated with 15 units of daxibotulinumtoxinA per platysmal band
DRUG	DaxibotulinumtoxinA 20 units	Subjects will be treated with 20 units of daxibotulinumtoxinA per platysmal band

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2024-01-26
• Last updated: 2025-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study