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BOTOX for the Treatment of Platysma Prominence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915067
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
To assess the efficacy and safety of BOTOX in adults with moderate to severe platysma prominence

Condition or disease Intervention/treatment Phase
Platysma Prominence Drug: BOTOX High Dose Drug: BOTOX Low Dose Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 23, 2019
Actual Primary Completion Date : April 16, 2020
Actual Study Completion Date : April 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Active Comparator: BOTOX High Dose
BOTOX High Dose will be injected into the platysma muscle on Day 1.
Drug: BOTOX High Dose
BOTOX will be injected into the platysma muscle

Active Comparator: BOTOX Low Dose
BOTOX Low Dose will be injected into the platysma muscle on Day 1.
Drug: BOTOX Low Dose
BOTOX will be injected into the platysma muscle

Placebo Comparator: Placebo
Placebo will be injected into the platysma muscle on Day 1.
Drug: Placebo
Placebo will be injected into the platysma muscle




Primary Outcome Measures :
  1. Achievement of improvement as rated by investigator using the clinician platysma scale [ Time Frame: 14 Days ]
    The investigator evaluates the participant's Platysma Prominence severity using a 5-grade scale where 1 = minimal and 5 = extreme

  2. To evaluate the safety of BOTOX compared with placebo in participants with moderate to severe platysma prominence based on incidence of adverse events [ Time Frame: 4 Months ]
    Number of Patients who experienced one or more Treatment Emergent Adverse Event (TEAE)

  3. To evaluate the safety of BOTOX compared with placebo in participants with moderate to severe platysma prominence based on change from baseline in pulse rate [ Time Frame: 4 Months ]
    Participants with a clinically relevant change from baseline in pulse rate

  4. To evaluate the safety of BOTOX compared with placebo in participants with moderate to severe platysma prominence based on change from baseline in systolic and diastolic blood pressure (BP) [ Time Frame: 4 Months ]
    Participants with a clinically relevant change from baseline in systolic and diastolic BP

  5. To evaluate the safety of BOTOX compared with placebo in participants with moderate to severe platysma prominence based on change from baseline in respiration rate [ Time Frame: 4 Months ]
    Participants with a clinically relevant change from baseline in respiration rate


Secondary Outcome Measures :
  1. Achievement of improvement as rated by participant using the participant platysma scale [ Time Frame: 14 Days ]
    The participant evaluates their own Platysma Prominence severity using a 5-grade scale where 1 = minimal and 5 = extreme



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Not a woman of childbearing potential (WOCBP) OR
    2. 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915067


Locations
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United States, California
Skincare & Laser Physicians of Beverly Hills
Los Angeles, California, United States, 90069
United States, Florida
Skin Research Institute LLC
Coral Gables, Florida, United States, 33146
United States, Illinois
DeNova Research dba Arano, LLC
Chicago, Illinois, United States, 60611
United States, Maryland
Maryland Laser Skin and Vein
Hunt Valley, Maryland, United States, 21030
United States, New York
The Center for Dermatology, Cosmetics, & Laser Surgery
Mount Kisco, New York, United States, 10549
United States, Tennessee
The Practice of Brian S. Biesman, MD
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas Plastic Surgery Institute
Dallas, Texas, United States, 75231
Canada, British Columbia
Dr. Shannon Humphrey Inc.
Vancouver, British Columbia, Canada, V5Z 4E1
Pacific Derm
Vancouver, British Columbia, Canada, V6H 4E1
Canada, Ontario
Dermetics
Burlington, Ontario, Canada, L7N 3N2
Sweat Clinics of Canada
Toronto, Ontario, Canada, M5R 3N8
Bertucci MedSpa
Woodbridge, Ontario, Canada, L4L 8E2
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Warren Tong Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03915067    
Other Study ID Numbers: 1936-201-008
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication, and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents