DaxibotulinimtoxinA for Treatment of Platysmal Neck Bands
NCT ID: NCT06225492
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2024-01-01
2025-01-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DaxibotulinumtoxinA 20 units
Subjects will receive 20 units of daxibotulinumtoxinA per platysmal band, up to 2 anterior bands and 2 lateral bands.
DaxibotulinumtoxinA 20 units
Subjects will be treated with 20 units of daxibotulinumtoxinA per platysmal band
DaxibotulinumtoxinA 15 units
Subjects will receive 15 units of daxibotulinumtoxinA per platysmal band, up to 2 anterior bands and 2 lateral bands.
DaxibotulinumtoxinA 15 units
Subjects will be treated with 15 units of daxibotulinumtoxinA per platysmal band
Interventions
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DaxibotulinumtoxinA 15 units
Subjects will be treated with 15 units of daxibotulinumtoxinA per platysmal band
DaxibotulinumtoxinA 20 units
Subjects will be treated with 20 units of daxibotulinumtoxinA per platysmal band
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
31 Years
ALL
Yes
Sponsors
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Main Line Center for Laser Surgery
OTHER
Responsible Party
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Kachiu Lee, MD
Physician
Principal Investigators
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Kachiu Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Physician
Locations
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Main Line Center for Laser Surgery
Ardmore, Pennsylvania, United States
Countries
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Other Identifiers
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DAXI0823
Identifier Type: -
Identifier Source: org_study_id
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