Aging Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 1, 2026 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 31 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Main Line Center for Laser Surgery | Ardmore | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Main Line Center for Laser Surgery |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of DaxibotulinumtoxinA for platysmal neck bands measured on Platysmal Neck Banding Scale | Platysmal Neck Banding Scale (Scored on a 1-5 scale with 5 being the most severe) | 12 months | |
Secondary | 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) | 12 months |
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