Platysma ProminencePhase 3NCT04949399
A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence
A Phase 3 study testing OnabotulinumtoxinA in people with Platysma Prominence, run by AbbVie at 30 sites in 2 countries.
Trial 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. 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?
- Yes, some participants may receive a placebo
- How many people
- 408 participants
- Where
- 30 sitesin 2 countries
- Study dates
- 8 Jul 2021to 20 Dec 2022
- 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
- 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
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
- 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
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States26 sites
SkinDC /ID# 229251
Arlington, Virginia, 22209
Aesthetic Center at Woodholme /ID# 229836
Baltimore, Maryland, 21208-6391
Susan H. Weinkle MD /ID# 229419
Bradenton, Florida, 34209-5642
Aesthetic Solutions /ID# 229241
Chapel Hill, North Carolina, 27517-9901
Dallas Plastic Surgery Institute /ID# 229258
Dallas, Texas, 75231
Aventiv Research Dublin /ID# 229254
Dublin, Ohio, 43016
Clinical Testing of Beverly Hills /ID# 229946
Encino, California, 91436-2124
Advanced Research Associates - Glendale /ID# 229256
Glendale, Arizona, 85308
Maryland Dermatology Laser, Skin, & Vein Institute /ID# 229260
Hunt Valley, Maryland, 21030-3216
Laser and Skin Surgery Center of Indiana /ID# 229515
Indianapolis, Indiana, 46260-2386
Dermatology Research Associates /ID# 229949
Los Angeles, California, 90045
Coleman Center For Cosmetic Dermatologic Surgery /ID# 229414
Metairie, Louisiana, 70006
Image Dermatology, P.C. /ID# 229244
Montclair, New Jersey, 07042
Nashville Center for Laser and Facial Surgery /ID# 229237
Nashville, Tennessee, 37203-1513
Delricht Research /ID# 229248
New Orleans, Louisiana, 70115
Laser & Skin Surgery Center of New York /ID# 229423
New York, New York, 10016-4974
Steve Yoelin MD Medical Associate Inc /ID# 229420
Newport Beach, California, 92663
KGL Skin Study Center, LLC /ID# 229253
Newtown Square, Pennsylvania, 19073-2228
Cosmetic Laser Dermatology /ID# 229245
San Diego, California, 92121-2119
Ava T. Shamban MD - Santa Monica. /ID# 229421
Santa Monica, California, 90404-2208
Clear Dermatology & Aesthetics Center /ID# 229252
Scottsdale, Arizona, 85255-4134
Art of Skin MD /ID# 229255
Solana Beach, California, 92075-2228
Premier Clinical Research /ID# 229261
Spokane, Washington, 99202
Research Institute of the Southeast, LLC /ID# 229234
West Palm Beach, Florida, 33401-2712
DMR Research PLLC /ID# 229938
Westport, Connecticut, 06880
Wilmington Dermatology Center /ID# 229246
Wilmington, North Carolina, 28403
Canada4 sites
Dermetics Cosmetic Dermatology /ID# 229482
Burlington, Ontario, L7N 3N2
Dr Melinda Gooderham Medicine Profession /ID# 229456
Cobourg, Ontario, K9A 0Z4
The Center For Dermatology /ID# 229481
Richmond Hill, Ontario, L4B 1A5
Humphrey Cosmetic Dermatology /ID# 229522
Vancouver, British Columbia, V5Z 4E1
About this study
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
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 a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study.
Participants will attend regular monthly visits during the study at the study site.
- Conditions
- Platysma Prominence
- Being tested
- OnabotulinumtoxinA, Placebo
- Keywords
- Platysma Prominence, OnabotulinumtoxinA, BOTOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
Also called BOTOX
Injection
PlaceboDrug
Saline Injection
| Study group | Role | What they receive |
|---|---|---|
| BOTOX | Experimental | BOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 Receives: Drug: OnabotulinumtoxinA |
| Placebo | Placebo comparator | Placebo will be injected into the platysma muscle on Day 1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Enrollment to Day 120
Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement From Baseline Based on Both Investigator's Assessment Using C-APPS and Participant's Self-Assessment Using P-APPS, at Maximum Contraction at Day 14
The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
The Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
Measured: Day 14
Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14
The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
Measured: Day 14
Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self- Assessment Using P-APPS at Maximum Contraction at Day 14
The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
Measured: Day 14
Secondary outcomes (12)
Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
Measured: Day 14, 30, 60, 90, and 120
Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
Measured: Day 14, 30, 60, 90, and 120
Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14
The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied).
Measured: Day 14
Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline) at Day 14
The BAS-PP 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) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).
Measured: Day 14
Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14
The BAS-PP 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) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).
Measured: Day 14
Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14
The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher summary scores (range: 7-35) indicating greater negative psychosocial impact from the appearance of the neck and lower face. For change from baseline in the ANLFQ: Impacts summary score, positive values indicate worsening and negative values indicate improvement in the psychosocial impact.
Measured: Day 14
Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
The C-APPS evaluates platysma prominence severity and is a static measurement encompassing visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
Measured: Day 14, 30, 60, 90, and 120
Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
Measured: Day 14, 30, 60, 90, and 120
Percentage of Participants Who Achieved a Rating of Minimal or Mild According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14
The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
Measured: Day 14
Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14
The ANLFQ: Satisfaction scale assesses how satisfied the participants are with the treatment they received for the appearance of their neck and lower face. Item 5 is a verbal descriptor scale ranging from 1 (Very satisfied) to 5 (Very dissatisfied).
Measured: Day 14
Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 2 (Jawline) at Day 14
The BAS-PP 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) where items are rated from 1 (Not at all bothered) to 5 (Extremely bothered).
Measured: Day 14
Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90
The ANLFQ: Impacts scale assesses the psychosocial impact of the appearance of the neck and lower face. All items are rated on a 5-point Verbal Descriptor Scale ranging from 1 (Never) to 5 (All of the time), with higher scores indicating greater negative impact from the appearance of the neck and lower face.
Measured: Days 30, 60, and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start8 Jul 2021
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Platysma ProminenceStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949399
- Sponsor's protocol ID
- M21-309
- Status last verified
- Oct 2024
- First submitted
- 25 Jun 2021
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04949399
- Acronym / sponsor ID
- M21-309
- Conditions
- Platysma Prominence
- Keywords
- Platysma Prominence, OnabotulinumtoxinA, BOTOX
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Posted 20 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study.
Participants will attend regular monthly visits during the study at the study site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOTOX | Experimental | Drug: OnabotulinumtoxinABOTOX (OnabotulinumtoxinA) was injected into the platysma muscle on Day 1 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be injected into the platysma muscle on Day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinAAlso: BOTOXInjection | Drug | BOTOX |
| PlaceboSaline Injection | Drug | Placebo |
Primary outcome
Number of Participants With Adverse Events
Time frame: Enrollment 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.
Composite Achievement of Grade 1 or 2 (Minimal or Mild) and at Least a 2-Grade Improvement From Baseline Based on Both Investigator's Assessment Using C-APPS and Participant's Self-Assessment Using P-APPS, at Maximum Contraction at Day 14
Time frame: Day 14
The Clinician Allergan Platysma Prominence Scale (C-APPS) evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme. The Participant Allergan Platysma Prominence Scale (P-APPS) evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
Achievement of at Least a 2-grade Improvement From Baseline Based on the Investigator's Assessment Using C-APPS at Maximum Contraction at Day 14
Time frame: Day 14
The C-APPS evaluates platysma prominence severity and is a static measurement encompassing the investigator's visual examination of the platysma muscle at maximum contraction, ranging from 1 - Minimal to 5- Extreme.
Achievement of at Least a 2-grade Improvement From Baseline Based on the Participant's Self- Assessment Using P-APPS at Maximum Contraction at Day 14
Time frame: Day 14
The P-APPS evaluates platysma prominence severity and is a single-item measure that is accompanied by a 5-grade photonumeric scale for participants to self-assess the severity of their platysma prominence at maximum contraction, ranging from 1 - Minimal to 5 - Extreme.
12 secondary outcomes
Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
Time frame: Day 14, 30, 60, 90, and 120
Percentage of Participants Who Achieved Grade 1 or 2 (Minimal or Mild) According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
Time frame: Day 14, 30, 60, 90, and 120
Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14
Time frame: Day 14
Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the Bother Assessment Scale - Platysma Prominence (BAS-PP) Scale Item 2 (Jawline) at Day 14
Time frame: Day 14
Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 1 (Vertical Neck Bands) at Day 14
Time frame: Day 14
Change From Baseline on the Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts Summary Score at Day 14
Time frame: Day 14
Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Investigator's Assessment Using C-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
Time frame: Day 14, 30, 60, 90, and 120
Percentage of Participants Who Achieved at Least 1-Grade Improvement From Baseline Based on Participant's Assessment Using P-APPS at Maximum Contraction at Days 14, 30, 60, 90, and 120
Time frame: Day 14, 30, 60, 90, and 120
Percentage of Participants Who Achieved a Rating of Minimal or Mild According to Participant's Assessment Using P-APPS at Maximum Contraction at Days 14
Time frame: Day 14
Percentage of Participants With Responses of "Satisfied" or "Very Satisfied" on the ANLFQ: Satisfaction (Follow-up) Item 5 (Effect of Treatment) at Day 14
Time frame: Day 14
Percentage of Participants With Responses of 'Not at All Bothered' or 'A Little Bothered' on the BAS-PP Scale Item 2 (Jawline) at Day 14
Time frame: Day 14
Change From Baseline on the ANLFQ: Impacts Summary Score at Days 30, 60, and 90
Time frame: Days 30, 60, and 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
Related trials for Platysma Prominence
Active, not recruitingPhase 3
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
Neuromuscular Agents, Peripheral Nervous System Agents
Active, not recruitingPhase 3
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States
Neuromuscular Agents, Peripheral Nervous System Agents
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
30 sites in 2 countries: see every site and its status.
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 30 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 4 inclusion and 8 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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. Some participants in this study may receive a placebo. 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 20 Nov 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: Enrollment to Day 120). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2024.