DaxibotulinimtoxinA for Treatment of Platysmal Neck Bands

M

Main Line Center for Laser Surgery

Status and phase

Enrolling
Phase 4

Conditions

Aging

Treatments

Drug: DaxibotulinumtoxinA 20 units
Drug: DaxibotulinumtoxinA 15 units

Study type

Interventional

Funder types

Other

Identifiers

NCT06225492
DAXI0823

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

31+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

DaxibotulinumtoxinA 20 units
Experimental group
Description:
Subjects will receive 20 units of daxibotulinumtoxinA per platysmal band, up to 2 anterior bands and 2 lateral bands.
Treatment:
Drug: DaxibotulinumtoxinA 20 units
DaxibotulinumtoxinA 15 units
Experimental group
Description:
Subjects will receive 15 units of daxibotulinumtoxinA per platysmal band, up to 2 anterior bands and 2 lateral bands.
Treatment:
Drug: DaxibotulinumtoxinA 15 units

Trial contacts and locations

1

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Central trial contact

Jessica Plugis

Data sourced from clinicaltrials.gov

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