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A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence

Sponsor
Allergan (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04949399
Collaborator
(none)
400
Enrollment
30
Locations
2
Arms
17.1
Anticipated Duration (Months)
13.3
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence.

Study doctors will randomize participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study in the United States and Canada.

Participants will receive either intramuscular injections of onabotulinumtoxinA (BOTOX) or placebo.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Multicenter, Randomized, Double Blind, Placebo Controlled 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 :
Jul 8, 2021
Anticipated Primary Completion Date :
Dec 12, 2022
Anticipated Study Completion Date :
Dec 12, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: BOTOX

BOTOX will be injected into the platysma muscle on Day 1

Drug: OnabotulinumtoxinA
Injection
Other Names:
  • BOTOX

    		•
    Placebo Comparator: Placebo

    Placebo will be injected into the platysma muscle on Day 1

    Drug: Placebo
    Injection

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Adverse Events [Day -14 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 casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.

    2. Composite Change as assessed by both the Clinician Platysma Scale and Participant Platysma Scale [Day 1 to Day 14]

      The Clinician Platysma Scale evaluates platysma prominence at maximum contraction and is a static measurement encompassing visual examination of the platysma muscle at maximum contraction ranging from 1 - Minimal to 5- Extreme. The Participant Platysma Scale evaluates platysma prominence at maximum contraction and is a single-item measure that is accompanied by a 5-grade photonumeric scale ranging from 1 - Minimal to 5 - Extreme.

    Secondary Outcome Measures

    1. Change in improvement as rated by investigator using the Clinician Platysma Scale [Day 1 to Day 14]

      The Clinician Platysma Scale evaluates platysma prominence at maximum contraction and is a static measurement encompassing visual examination of the platysma muscle at maximum contraction ranging from 1- Minimal to 5- Extreme.

    2. Percentage of patients with satisfaction with appearance of the neck and lower face as measured by The Appearance of Neck and Lower Face Questionnaire: Satisfaction [Day 14]

      The Appearance of Neck and Lower Face Questionnaire: Satisfaction is a 11-item measure that assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face.

    3. Percentage of Participants with Achievement of Responses of Not at all Bothered or a Little Bothered on the Bother Assessment Scale Item 1 [Day 14]

      The Bother Assessment Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their lower face and neck ranging from 1 (Not at all bothered) to 5 (Extremely bothered).

    4. Percentage of Participants with achievement of responses of Not at all bothered or A little bothered on the Bother Assessment Scale Item 2 (Jawline) [Day 14]

      The Bother Assessment Scale is a 2-item measure that asks participants to rate how bothered they are by the appearance of their vertical neck bands (Item 1) and jawline (Item 2) ranging from 1 (Not at all bothered) to 5 (Extremely bothered).

    5. Change from baseline on the Appearance of Neck and Lower Face Questionnaire: Impacts summary score [Day 1 to Day 14]

      The Appearance of Neck and Lower Face Questionnaire: Impacts is a 7-item measure that assesses the psychosocial impact of the appearance of the neck and lower face.

    6. Percentage of Participants with achievement of a rating of Minimal or Mild according to investigator's assessment using Clinician Platysma Scale [Day 14]

      The Clinician Platysma Scale evaluates platysma prominence at maximum contraction and is a static measurement encompassing visual examination of the platysma muscle at maximum contraction ranging from 1 - Minimal to 5- Extreme.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study specific procedures

    Are willing and able to comply with procedures required in the protocol

    Adult male or female, at least 18 years old at the time of signing the informed consent

    Good health as determined by medical history, physical examination, vital signs, and investigator's judgment

    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

    Females who are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study

    Known immunization or hypersensitivity to any botulinum toxin serotype

    History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months

    Lower facial and neck hair, scarring (e.g., acne), or other abnormal variations that may interfere with photography (such that photograph is not acceptable)

    Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of interest

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Advanced Research Associates - Glendale /ID# 229256 Glendale Arizona United States 85308
    2 Clear Dermatology & Aesthetics Center /ID# 229252 Scottsdale Arizona United States 85255-4134
    3 Clinical Testing of Beverly Hills /ID# 229946 Encino California United States 91436-2124
    4 Dermatology Research Associates /ID# 229949 Los Angeles California United States 90045
    5 Steve Yoelin MD Medical Assoc. Inc /ID# 229420 Newport Beach California United States 92663-3311
    6 Cosmetic Laser Dermatology /ID# 229245 San Diego California United States 92121-2119
    7 Ava T. Shamban MD - Santa Monica. /ID# 229421 Santa Monica California United States 90404-2208
    8 Art of Skin MD /ID# 229255 Solana Beach California United States 92075-2228
    9 DMR Research PLLC /ID# 229938 Westport Connecticut United States 06880-5369
    10 Susan H. Weinkle MD /ID# 229419 Bradenton Florida United States 34209-5642
    11 Research Institute of the Southeast, LLC /ID# 229234 West Palm Beach Florida United States 33401-2712
    12 Laser and Skin Surgery Center of Indiana /ID# 229515 Indianapolis Indiana United States 46260-2386
    13 Coleman Center For Cosmetic Dermatologic Surgery /ID# 229414 Metairie Louisiana United States 70006
    14 Delricht Research /ID# 229248 New Orleans Louisiana United States 70115
    15 Aesthetic Center at Woodholme /ID# 229836 Baltimore Maryland United States 21208-6391
    16 Maryland Dermatology Laser, Skin, & Vein Institute /ID# 229260 Hunt Valley Maryland United States 21030-3216
    17 Image Dermatology, P.C. /ID# 229244 Montclair New Jersey United States 07042
    18 Laser & Skin Surgery Center of New York /ID# 229423 New York New York United States 10016-4974
    19 Aesthetic Solutions /ID# 229241 Chapel Hill North Carolina United States 27517-9901
    20 Wilmington Dermatology Center /ID# 229246 Wilmington North Carolina United States 28403
    21 Aventiv Research Dublin /ID# 229254 Dublin Ohio United States 43016
    22 KGL Skin Study Center, LLC /ID# 229253 Newtown Square Pennsylvania United States 19073-2228
    23 Nashville Center for Laser and Facial Surgery /ID# 229237 Nashville Tennessee United States 37203-1513
    24 Dallas Plastic Surgery Institute /ID# 229258 Dallas Texas United States 75231
    25 SkinDC /ID# 229251 Arlington Virginia United States 22209
    26 Premier Clinical Research /ID# 229261 Spokane Washington United States 99202
    27 Humphrey Cosmetic Dermatology /ID# 229522 Vancouver British Columbia Canada V5Z 4E1
    28 Dermetics Cosmetic Dermatology /ID# 229482 Burlington Ontario Canada L7N 3N2
    29 Dr Melinda Gooderham Medicine Profession /ID# 229456 Cobourg Ontario Canada K9A 0Z4
    30 The Center For Dermatology /ID# 229481 Richmond Hill Ontario Canada L4B 1A5

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: ALLERGAN INC., Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT04949399
    Other Study ID Numbers:
    • M21-309
    First Posted:
    Jul 2, 2021
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Allergan
    Platysma Prominence
    OnabotulinumtoxinA
    BOTOX
    Additional relevant MeSH terms:
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Jul 27, 2022