A research study to evaluate safety and how well the study drug, BOTOX works for the treatment of platysma prominence (neck bands).
- Conditions
- Moderate and severe platysma prominenceTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2021-000240-22-DE
- Lead Sponsor
- AbbVie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 426
- Adult male or female = 18 years of age
- Body mass index (BMI) rounded to whole number of at least 18 kg/m2, but less than 30 kg/m2, at screening
- Ability to correctly and consistently maximally contract their platysma muscle
- Moderate (Grade 3) or severe (Grade 4) platysma prominence on both left and right sides (severities are not required to be identical on both sides), as determined at maximum contraction at screening and on Day 1 by the investigator using the C-APPS and on Day 1 by the subject using the P-APPS
- Subjects with responses of Somewhat bothered, A lot bothered, or Extremely bothered on the BAS-PP Item 1 (vertical neck bands) and
BAS-PP Item 2 (jawline), as determined by the subject at Day 1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
- No appearance of vertical neck bands at rest, extreme hypertrophic platysma bands at maximum contraction, or excessively loose skin in lower face, neck, and décolletage area
- No prior exposure to botulinum toxin of any serotype to the mid/upper face or any other part of the body within 4 months prior to Day 1, or to the lower face and/or neck within 6 months prior to Day 1
- No anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study drug)
- No prior treatments to the lower face and/or neck such as radiation, surgical treatment (including but not limited to cosmetic procedures such as facelift, platysmaplasty or other reconstructive surgery), cosmetic/surgical suspension threads, non-HA soft tissue/dermal fillers, synthetic implantation, and/or autologous fat transplantation
- This is not an exhaustive list of all eligibility criteria. Please reference study protocol for full details.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the safety and efficacy of BOTOX with placebo for the treatment of platysma prominence in subjects with moderate to severe platysma prominence at maximum contraction<br>;Secondary Objective: Not Applicable;Primary end point(s): Coprimary: Achievement of at least a 2-grade improvement from<br>baseline based on the following:<br>- Investigator's assessment using C-APPS at maximum contraction at Day 14<br>- Subject's self-assessment using P-APPS at maximum contraction at Day 14<br><br>Safety: <br>- Incidence of adverse events (AEs)<br>;Timepoint(s) of evaluation of this end point: Timepoints of evaluation of the primary endpoints: Day 14
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Achievement of a rating of Minimal or Mild according to subject's self- assessment using P-APPS at maximum contraction at Day 14<br>- Responses of Satisfied or Very satisfied on the ANLFQ: Satisfaction (Follow-up) Item 5 (effect of treatment) at Day 14<br>- Responses of Not at all bothered or A little bothered on the BAS-PP Item 2 (jawline) at Day 14<br>- Responses of Not at all bothered or A little bothered on the BAS-PP Item 1 (vertical neck bands) at Day 14<br>- Change from baseline on the ANLFQ: Impacts summary score at Day 14<br>- Change from baseline on the ANLFQ: Impacts summary score at Days 30, 60, and 90<br><br>;Timepoint(s) of evaluation of this end point: Timepoints of evaluation of the secondary endpoints for EU regulatory agencies: Day 14 (most endpoints), and Day 30, 60, and 90 (last endpoint listed)