Skip to main content
OpenTrials
Completed

NCT Number: NCT03915067

BOTOX® for the Treatment of Platysma Prominence

To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma prominence.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Platysma Prominence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Humphrey Cosmetic Dermatology /ID# 236591, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period
  • A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) OR
  • A WOCBP who agrees to follow the studies contraceptive guidance during the treatment and follow-up period through study exit.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this study's protocol

Exclusion criteria

  • Any medical condition that may put the participant at increased medical risk with exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
  • Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
  • Anticipated need for surgery or overnight hospitalization during the study
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
  • Females who are pregnant, nursing, or planning a pregnancy during the study
  • Known immunization or hypersensitivity to any botulinum toxin serotype
  • History of alcohol or drug abuse within 12 months of the study
  • Participant has tattoos, jewelry, or clothing that cannot be removed, and that obscure the neck

Treatment and study plan

BOTOX® purified neurotoxin complex

Drug

BOTOX® superficial intramuscular injections.

Other names: Botulinum toxin type A purified neurotoxin complex

Placebo

Drug

Placebo injections.

Primary outcomes

  1. Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS)

    Time frame: Day 14

    The investigator evaluated the participant's platysma prominence severity using a 5-grade scale C-APPS at maximum contraction where 1= minimal, and 5= extreme. Higher values indicate worsening condition. Data is reported for participants who achieved at least a 1-grade improvement rated on the C-APPS. Percentages are rounded off to whole number at the nearest decimal. Cochran-Mantel-Haenszel (CMH) chi-squared test was used for analysis.

  2. Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)

    Time frame: From the first dose of study drug up to end of study (up to Day 120)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events are defined as any event that began or worsened in severity on or after the first dose of study drug or any AE that was present before the first dose of study intervention, but increased in severity or became serious after the first dose of study intervention.

  3. Pulse Rate at Baseline

    Time frame: Baseline (Day 1)

    Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

  4. Change From Baseline in Pulse Rate at Day 7

    Time frame: Baseline; Day 7

    Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

  5. Change From Baseline in Pulse Rate at Day 14

    Time frame: Baseline; Day 14

    Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

  6. Change From Baseline in Pulse Rate at Day 30

    Time frame: Baseline; Day 30

    Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

  7. Change From Baseline in Pulse Rate at Day 60

    Time frame: Baseline; Day 60

    Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

  8. Change From Baseline in Pulse Rate at Day 90

    Time frame: Baseline; Day 90

    Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

  9. Change From Baseline in Pulse Rate at Day 120

    Time frame: Baseline; Day 120

    Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.

  10. Systolic and Diastolic Blood Pressure (BP) at Baseline

    Time frame: Baseline (Day 1)

    Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

  11. Change From Baseline in Systolic and Diastolic BP at Day 7

    Time frame: Baseline; Day 7

    Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

  12. Change From Baseline in Systolic and Diastolic BP at Day 14

    Time frame: Baseline; Day 14

    Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

  13. Change From Baseline in Systolic and Diastolic BP at Day 30

    Time frame: Baseline; Day 30

    Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

  14. Change From Baseline in Systolic and Diastolic BP at Day 60

    Time frame: Baseline; Day 60

    Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

  15. Change From Baseline in Systolic and Diastolic BP at Day 90

    Time frame: Baseline; Day 90

    Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

  16. Change From Baseline in Systolic and Diastolic BP at Day 120

    Time frame: Baseline; Day 120

    Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.

  17. Respiratory Rate at Baseline

    Time frame: Baseline (Day 1)

    Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

  18. Change From Baseline in Respiratory Rate at Day 7

    Time frame: Baseline; Day 7

    Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

  19. Change From Baseline in Respiratory Rate at Day 14

    Time frame: Baseline; Day 14

    Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

  20. Change From Baseline in Respiratory Rate at Day 30

    Time frame: Baseline; Day 30

    Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

  21. Change From Baseline in Respiratory Rate at Day 60

    Time frame: Baseline; Day 60

    Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

  22. Change From Baseline in Respiratory Rate at Day 90

    Time frame: Baseline; Day 90

    Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

  23. Change From Baseline in Respiratory Rate at Day 120

    Time frame: Baseline; Day 120

    Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

Secondary outcomes

  1. Percentage of Participants With at Least a 1-Grade Improvement at Day 14 as Rated by Participant Using the Participant Allergan Platysma Prominence Scale (P-APPS)

    Time frame: Day 14

    The participants evaluated their own Platysma Prominence severity using a 5-grade scale where 1= minimal, and 5= extreme. Higher values indicate worsening conditions. Data is reported for participants who achieved at least a 1-grade improvement rated on the P-APPS. Percentages are rounded off to whole number at the nearest decimal. CMH chi-squared test was used for analysis.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2019
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.