BOTOX for the Treatment of Platysma Prominence

• ClinicalTrials.gov Identifier: NCT03915067
• Recruitment Status: Completed
• First Posted: April 16, 2019
• Last Update Posted: April 14, 2021
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Director: Warren Tong; Allergan

More Information

Additional Information:

Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance. 

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT03915067
• Other Study ID Numbers: 1936-201-008
• First Posted: April 16, 2019
• Last Update Posted: April 14, 2021
• Last Verified: April 2021

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/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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