DaxibotulinimtoxinA for Treatment of Platysmal Neck Bands

Use of DaxibotulinimtoxinA Injection for Platysma Bands of the Neck

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Drug: DaxibotulinumtoxinA 20 units; Drug: DaxibotulinumtoxinA 15 units

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Ardmore, Pennsylvania, United States, 19003
      • Main Line Center for Laser Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• >30 years old
• Rating of 2, 3, or 4 on 5-point Merz Neck Scale
• No use of any botulinum toxin in the neck for the past 6 months

Exclusion Criteria:

• Pregnancy
• Prior adverse reaction or known hypersensitivity to neuromodulators treatment
• Connective tissue disorder
• Scar in the treatment area
• History of dysphagia and/or neuromuscular disorders (such as but not limited to Amyotrophic Lateral Sclerosis, Multiple sclerosis, Myasthenia Gravis, Lambert-Eaton syndrome, others per PI's discretion)
• Active infection in treatment area
• Active moderate or severe inflammatory disease in treatment area such as atopic dermatitis, psoriasis
• Prior treatment with neuromodulators in treatment area (neck) within the past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DaxibotulinumtoxinA 20 units; Subjects will receive 20 units of daxibotulinumtoxinA per platysmal band, up to 2 anterior bands and 2 lateral bands.	Drug: DaxibotulinumtoxinA 20 units; Subjects will be treated with 20 units of daxibotulinumtoxinA per platysmal band; Other Names: Daxxify
Experimental: DaxibotulinumtoxinA 15 units; Subjects will receive 15 units of daxibotulinumtoxinA per platysmal band, up to 2 anterior bands and 2 lateral bands.	Drug: DaxibotulinumtoxinA 15 units; Subjects will be treated with 15 units of daxibotulinumtoxinA per platysmal band; Other Names: Daxxify

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of DaxibotulinumtoxinA for platysmal neck bands measured on Platysmal Neck Banding Scale	Platysmal Neck Banding Scale (Scored on a 0-4 scale with 4 being the most severe)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate patient-reported outcomes (patient satisfaction with neck using FACE-Q scale)	Patient satisfaction with neck using FACE-Q scale (scored on a 1-100 scale with 100 being highest satisfaction)	3 months

Collaborators and Investigators

• Sponsor: Main Line Center for Laser Surgery
• Investigators: Principal Investigator: Kachiu Lee, MD, Physician

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Neuromuscular Agents; Acetylcholine Release Inhibitors; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: DAXI0823

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Final data from study is available to share upon request.
• IPD Sharing Time Frame: 5 years
• IPD Sharing Access Criteria: IRB approval
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes