E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate and severe platysma prominence |
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E.1.1.1 | Medical condition in easily understood language |
Platysma prominence manifests as an undesirable aesthetic effect on the neck as vertical bands and along the jawline with blunting resulting from repetitive platysma muscle contraction. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 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.
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E.4 | Principal exclusion criteria |
- 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Coprimary: Achievement of at least a 2-grade improvement from baseline based on the following: - Investigator's assessment using C-APPS at maximum contraction at Day 14 - Subject's self-assessment using P-APPS at maximum contraction at Day 14
Safety: - Incidence of adverse events (AEs)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Timepoints of evaluation of the primary endpoints: Day 14 |
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E.5.2 | 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 - Responses of Satisfied or Very satisfied on the ANLFQ: Satisfaction (Follow-up) Item 5 (effect of treatment) at Day 14 - Responses of Not at all bothered or A little bothered on the BAS-PP Item 2 (jawline) at Day 14 - Responses of Not at all bothered or A little bothered on the BAS-PP Item 1 (vertical neck bands) at Day 14 - Change from baseline on the ANLFQ: Impacts summary score at Day 14 - Change from baseline on the ANLFQ: Impacts summary score at Days 30, 60, and 90
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E.5.2.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
United States |
Germany |
Belgium |
Russian Federation |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end-of-study is defined as the date of the last visit of the last subject in the study. A subject is considered to have completed the study if he/she has completed all phases of the study including the Study Exit visit.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |