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Platysma ProminencePhase 3NCT05134649

A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence

A Phase 3 study testing OnabotulinumtoxinA in people with Platysma Prominence, run by AbbVie at 29 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 3, open-label extension study to evaluate the long-term safety of repeat BOTOX treatments in adult participants with Platysma Prominence. Participants who completed the lead-in Phase 3 Study M21-309 and met eligibility requirements could enroll in this open-label extension study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Platysma Prominence
What is being tested?
OnabotulinumtoxinA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
292 participants
Where
29 sitesin 2 countries
Study dates
16 Nov 2021to 18 Aug 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Completion of all phases of the lead-in Phase 3 study (Screening Period, Treatment Period [randomization/treatment with 4-month follow-up visit] and Study Exit visit)

Who cannot join

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

Trial locations and contacts

29 sites in 2 countries.

29 sites in 2 countries

United States25 sites

  • SkinDC /ID# 231989

    Arlington, Virginia, 22209

  • Aesthetic Center at Woodholme /ID# 231996

    Baltimore, Maryland, 21208-6391

  • Susan H. Weinkle MD /ID# 232001

    Bradenton, Florida, 34209-5642

  • Aesthetic Solutions /ID# 231978

    Chapel Hill, North Carolina, 27517-9901

  • Dallas Plastic Surgery Institute /ID# 231999

    Dallas, Texas, 75231

  • Aventiv Research Dublin /ID# 231994

    Dublin, Ohio, 43016

  • Clinical Testing of Beverly Hills /ID# 231986

    Encino, California, 91436-2124

  • Advanced Research Associates - Glendale /ID# 231997

    Glendale, Arizona, 85308

  • Maryland Dermatology Laser, Skin, & Vein Institute /ID# 232002

    Hunt Valley, Maryland, 21030-3216

  • Laser and Skin Surgery Center of Indiana /ID# 231983

    Indianapolis, Indiana, 46260-2386

  • Coleman Center For Cosmetic Dermatologic Surgery /ID# 231977

    Metairie, Louisiana, 70006

  • Image Dermatology, P.C. /ID# 231980

    Montclair, New Jersey, 07042

  • Nashville Center for Laser and Facial Surgery /ID# 231975

    Nashville, Tennessee, 37203-1513

  • Delricht Research /ID# 231985

    New Orleans, Louisiana, 70115

  • Laser & Skin Surgery Center of New York /ID# 231982

    New York, New York, 10016-4974

  • Steve Yoelin MD Medical Assoc. Inc /ID# 232004

    Newport Beach, California, 92663-3311

  • KGL Skin Study Center, LLC /ID# 231993

    Newtown Square, Pennsylvania, 19073-2228

  • Cosmetic Laser Dermatology /ID# 232414

    San Diego, California, 92121-2119

  • Ava T. Shamban MD - Santa Monica. /ID# 232000

    Santa Monica, California, 90404-2208

  • Clear Dermatology & Aesthetics Center /ID# 231990

    Scottsdale, Arizona, 85255-4134

  • Art of Skin MD /ID# 231995

    Solana Beach, California, 92075-2228

  • Premier Clinical Research /ID# 232003

    Spokane, Washington, 99202

  • Research Institute of the Southeast, LLC /ID# 231974

    West Palm Beach, Florida, 33401-2712

  • DMR Research PLLC /ID# 231998

    Westport, Connecticut, 06880-5369

  • Wilmington Dermatology Center /ID# 231981

    Wilmington, North Carolina, 28403

Other trials in United States

Canada4 sites

  • Dermetics Cosmetic Dermatology /ID# 239650

    Burlington, Ontario, L7N 3N2

  • Dr Melinda Gooderham Medicine Profession /ID# 239647

    Cobourg, Ontario, K9A 0Z4

  • The Center For Dermatology /ID# 239651

    Richmond Hill, Ontario, L4B 1A5

  • Humphrey Cosmetic Dermatology /ID# 239649

    Vancouver, British Columbia, V5Z 4E1

Other trials in Canada

About this study

Official title: Phase 3, Multicenter Open-label Extension Study to Evaluate the Safety of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence

This is a Phase 3, open-label extension study to evaluate the long-term safety of repeat BOTOX treatments in adult participants with Platysma Prominence. Participants who completed the lead-in Phase 3 Study M21-309 and met eligibility requirements could enroll in this open-label extension study.

Planned study enrollment was approximately 270 participants. Participants who met treatment criteria could receive up to 3 administrations of BOTOX. Day 1 (study entry) was the same day as Day 120/study exit visit of the lead-in Phase 3 study. The first administration of study drug could occur at the Day 1 visit, and the last administration of study drug could occur at the Day 180 visit (60 days prior to Day 240/study exit). Once a subject was enrolled in this study, monthly follow-up visits occurred.

Being tested
OnabotulinumtoxinA
Keywords
Platysma Prominence, BOTOX, OnabotulinumtoxinA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OnabotulinumtoxinADrug

    Also called BOTOX

    Intramuscular Injection

Study groups in NCT05134649
Study groupRoleWhat they receive
BOTOXExperimentalBOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle for up to 3 Cycles during study M21-323
Receives: Drug: OnabotulinumtoxinA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events

    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.

    Measured: 371 days (from enrollment in the lead-in study M21-309 through end of study M21-323)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2021
  2. Study start16 Nov 2021
  3. Primary completion18 Aug 2023
  4. Study completion18 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05134649
Sponsor's protocol ID
M21-323
Status last verified
Nov 2024
First submitted
15 Nov 2021
Last updated
5 Dec 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OnabotulinumtoxinA in people with Platysma Prominence, run by AbbVie at 29 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: 371 days (from enrollment in the lead-in study M21-309 through end of study M21-323)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05134649.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.

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