Platysma ProminencePhase 2NCT03915067

BOTOX® for the Treatment of Platysma Prominence

A Phase 2 study testing BOTOX® purified neurotoxin complex in people with Platysma Prominence, run by Allergan at 12 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma prominence. 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?: BOTOX® purified neurotoxin complex
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 171 participants
Where: 12 sitesin 2 countries
Study dates: 23 Apr 2019to 16 Apr 2020
Phase: Phase 2
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

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:
Not a woman of childbearing potential (WOCBP) OR
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 informed consent form (ICF) and in this study's protocol

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
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

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

United States7 sites

DeNova Research /ID# 238165
Chicago, Illinois, 60611
Skin Research Institute LLC /ID# 238126
Coral Gables, Florida, 33146-1837
Dallas Plastic Surgery Institute /ID# 236528
Dallas, Texas, 75231
MD Laser Skin & Vein /ID# 234532
Hunt Valley, Maryland, 21030
Skin Care and Laser Physicians of Beverly Hills /ID# 236518
Los Angeles, California, 90069
The Center for Dermatology Cosmetics & Laser Surgery /ID# 235624
Mount Kisco, New York, 10549-3028
The Practice of Brian S. Biesman MD PLLC /ID# 234461
Nashville, Tennessee, 37203

Other trials in United States

Canada5 sites

Dermetics Cosmetic Dermatology /ID# 236899
Burlington, Ontario, L7N 3N2
Sweat Clinics of Canada /ID# 236590
Toronto, Ontario, M5R 3N8
Humphrey Cosmetic Dermatology /ID# 236591
Vancouver, British Columbia, V5Z 4E1
Pacific Derm /ID# 238236
Vancouver, British Columbia, V6H 4E1
Bertucci MedSpa Inc. /ID# 236523
Woodbridge, Ontario, L4L 8E2

Other trials in Canada

About this study

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

To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma prominence.

Conditions: Platysma Prominence
Being tested: BOTOX® purified neurotoxin complex, Placebo

What participants receive

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

BOTOX® purified neurotoxin complexDrug
Also called Botulinum toxin type A purified neurotoxin complex
BOTOX® superficial intramuscular injections.
PlaceboDrug
Placebo injections.

Study groups in NCT03915067
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1. Receives: Drug: Placebo
BOTOX® Low Dose	Experimental	Participants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. Receives: Drug: BOTOX® purified neurotoxin complex
BOTOX® High Dose	Active comparator	Participants received BOTOX® High Dose as superficial intramuscular injections administered to the platysma muscle on Day 1. Receives: Drug: BOTOX® purified neurotoxin complex

What is being measured

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

Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS)
The investigator evaluated the participant's platysma prominence severity using a 5-grade scale C-APPS at maximum contraction where 1= minimal, and 5= extreme. Higher values indicate worsening condition. Data is reported for participants who achieved at least a 1-grade improvement rated on the C-APPS. Percentages are rounded off to whole number at the nearest decimal. Cochran-Mantel-Haenszel (CMH) chi-squared test was used for analysis.
Measured: Day 14
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)
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 causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events are defined as any event that began or worsened in severity on or after the first dose of study drug or any AE that was present before the first dose of study intervention, but increased in severity or became serious after the first dose of study intervention.
Measured: From the first dose of study drug up to end of study (up to Day 120)
Pulse Rate at Baseline
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Measured: Baseline (Day 1)
Change From Baseline in Pulse Rate at Day 7
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Measured: Baseline; Day 7
Change From Baseline in Pulse Rate at Day 14
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Measured: Baseline; Day 14
Change From Baseline in Pulse Rate at Day 30
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Measured: Baseline; Day 30
Change From Baseline in Pulse Rate at Day 60
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Measured: Baseline; Day 60
Change From Baseline in Pulse Rate at Day 90
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Measured: Baseline; Day 90
Change From Baseline in Pulse Rate at Day 120
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Measured: Baseline; Day 120
Systolic and Diastolic Blood Pressure (BP) at Baseline
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Measured: Baseline (Day 1)
Change From Baseline in Systolic and Diastolic BP at Day 7
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Measured: Baseline; Day 7
Change From Baseline in Systolic and Diastolic BP at Day 14
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Measured: Baseline; Day 14
Change From Baseline in Systolic and Diastolic BP at Day 30
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Measured: Baseline; Day 30
Change From Baseline in Systolic and Diastolic BP at Day 60
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Measured: Baseline; Day 60
Change From Baseline in Systolic and Diastolic BP at Day 90
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Measured: Baseline; Day 90
Change From Baseline in Systolic and Diastolic BP at Day 120
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Measured: Baseline; Day 120
Respiratory Rate at Baseline
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Measured: Baseline (Day 1)
Change From Baseline in Respiratory Rate at Day 7
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Measured: Baseline; Day 7
Change From Baseline in Respiratory Rate at Day 14
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Measured: Baseline; Day 14
Change From Baseline in Respiratory Rate at Day 30
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Measured: Baseline; Day 30
Change From Baseline in Respiratory Rate at Day 60
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Measured: Baseline; Day 60
Change From Baseline in Respiratory Rate at Day 90
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Measured: Baseline; Day 90
Change From Baseline in Respiratory Rate at Day 120
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Measured: Baseline; Day 120

Secondary outcomes (1)

Percentage of Participants With at Least a 1-Grade Improvement at Day 14 as Rated by Participant Using the Participant Allergan Platysma Prominence Scale (P-APPS)
The participants evaluated their own Platysma Prominence severity using a 5-grade scale where 1= minimal, and 5= extreme. Higher values indicate worsening conditions. Data is reported for participants who achieved at least a 1-grade improvement rated on the P-APPS. Percentages are rounded off to whole number at the nearest decimal. CMH chi-squared test was used for analysis.
Measured: Day 14

Timeline

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

23 Apr 201916 Apr 2020

First posted16 Apr 2019
Study start23 Apr 2019
Primary completion16 Apr 2020
Study completion16 Apr 2020

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Platysma ProminenceStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 171 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03915067
Sponsor's protocol ID: 1936-201-008
Status last verified: Apr 2023
First submitted: 29 Mar 2019
Last updated: 3 May 2023
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.

Publications

Humphrey S, Shimoga S, Kaufman J, Bank D, Biesman B, Harutunian C, West GS, Tong W, Patel V. Patient-Reported Outcomes After Treatment With OnabotulinumtoxinA for Platysma Prominence: Results From a Phase 2 Dose-Ranging Study. J Cosmet Dermatol. 2026 Apr;25(4):e70821. doi: 10.1111/jocd.70821.
PubMed 41933889
Garcia JK, Hopfinger RM, Foley C, Whyte J, Gauthier M, Foster B, Patel V. Development and validation of patient-reported outcome measures for platysma prominence. Curr Med Res Opin. 2025 Jul;41(7):1277-1290. doi: 10.1080/03007995.2025.2537898. Epub 2025 Jul 31.
PubMed 40704633
Rohrich RJ, Bertucci V, Dayan S, Jones D, Solish N, Rivers JK, Weiss RA, Muhn CY, Harutunian C, Park GS, Shimoga S, Lee E, Tong W. Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Platysma Prominence: A Randomized Phase 2 Dose-Ranging Study. Plast Reconstr Surg. 2025 Jan 1;155(1):79-88. doi: 10.1097/PRS.0000000000011472. Epub 2024 Apr 16.
PubMed 38640068

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Platysma Prominence trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03915067
Acronym / sponsor ID: 1936-201-008
Conditions: Platysma Prominence
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 171 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 23 Apr 2019 (actual)
Primary completion: 16 Apr 2020 (actual)
Study completion: 16 Apr 2020 (actual)
First posted: 16 Apr 2019 (actual)
Results: Posted 3 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma prominence.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants received matching placebo as superficial intramuscular injections administered to the platysma muscle on Day 1.
BOTOX® Low Dose	Experimental	Drug: BOTOX® purified neurotoxin complexParticipants received BOTOX® Low Dose as superficial intramuscular injections administered to the platysma muscle on Day 1.
BOTOX® High Dose	Active comparator	Drug: BOTOX® purified neurotoxin complexParticipants received BOTOX® High Dose as superficial intramuscular injections administered to 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 (5 listed)

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:
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this study's protocol

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
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

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
BOTOX® purified neurotoxin complexAlso: Botulinum toxin type A purified neurotoxin complexBOTOX® superficial intramuscular injections.	Drug	BOTOX® High Dose, BOTOX® Low Dose
PlaceboPlacebo injections.	Drug	Placebo

Primary outcome

Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS)
Time frame: Day 14
The investigator evaluated the participant's platysma prominence severity using a 5-grade scale C-APPS at maximum contraction where 1= minimal, and 5= extreme. Higher values indicate worsening condition. Data is reported for participants who achieved at least a 1-grade improvement rated on the C-APPS. Percentages are rounded off to whole number at the nearest decimal. Cochran-Mantel-Haenszel (CMH) chi-squared test was used for analysis.
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)
Time frame: From the first dose of study drug up to end of study (up 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 causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Treatment-emergent adverse events are defined as any event that began or worsened in severity on or after the first dose of study drug or any AE that was present before the first dose of study intervention, but increased in severity or became serious after the first dose of study intervention.
Pulse Rate at Baseline
Time frame: Baseline (Day 1)
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Change From Baseline in Pulse Rate at Day 7
Time frame: Baseline; Day 7
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Change From Baseline in Pulse Rate at Day 14
Time frame: Baseline; Day 14
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Change From Baseline in Pulse Rate at Day 30
Time frame: Baseline; Day 30
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Change From Baseline in Pulse Rate at Day 60
Time frame: Baseline; Day 60
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Change From Baseline in Pulse Rate at Day 90
Time frame: Baseline; Day 90
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Change From Baseline in Pulse Rate at Day 120
Time frame: Baseline; Day 120
Participants were seated for at least 5 minutes, and pulse was counted over 60 seconds and recorded.
Systolic and Diastolic Blood Pressure (BP) at Baseline
Time frame: Baseline (Day 1)
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Change From Baseline in Systolic and Diastolic BP at Day 7
Time frame: Baseline; Day 7
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Change From Baseline in Systolic and Diastolic BP at Day 14
Time frame: Baseline; Day 14
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Change From Baseline in Systolic and Diastolic BP at Day 30
Time frame: Baseline; Day 30
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Change From Baseline in Systolic and Diastolic BP at Day 60
Time frame: Baseline; Day 60
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Change From Baseline in Systolic and Diastolic BP at Day 90
Time frame: Baseline; Day 90
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Change From Baseline in Systolic and Diastolic BP at Day 120
Time frame: Baseline; Day 120
Participants were seated for at least 5 minutes, and systolic and diastolic BP was measured.
Respiratory Rate at Baseline
Time frame: Baseline (Day 1)
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Change From Baseline in Respiratory Rate at Day 7
Time frame: Baseline; Day 7
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Change From Baseline in Respiratory Rate at Day 14
Time frame: Baseline; Day 14
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Change From Baseline in Respiratory Rate at Day 30
Time frame: Baseline; Day 30
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Change From Baseline in Respiratory Rate at Day 60
Time frame: Baseline; Day 60
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Change From Baseline in Respiratory Rate at Day 90
Time frame: Baseline; Day 90
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.
Change From Baseline in Respiratory Rate at Day 120
Time frame: Baseline; Day 120
Participants were seated for at least 5 minutes, and breaths were counted for 30 seconds and multiplied by 2.

1 secondary outcome

Percentage of Participants With at Least a 1-Grade Improvement at Day 14 as Rated by Participant Using the Participant Allergan Platysma Prominence Scale (P-APPS)
Time frame: Day 14

Results and safety

Results posted to the registry on 3 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	57	47
BOTOX® Low Dose	59	50
BOTOX® High Dose	55	49

Primary outcome: Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS)

Time frame: Day 14. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo n = 50	BOTOX® Low Dose n = 54	BOTOX® High Dose n = 51
Value	12.0 (3.0 to 21.0)	77.8 (66.7 to 88.9)	88.2 (79.4 to 97.1)

Placebo vs BOTOX® Low Dose: Rate Difference: 65.8 (95% CI 51.5 to 80.1), p <0.0001, Cochran-Mantel-Haenszel
Placebo vs BOTOX® High Dose: Rate Difference: 76.2 (95% CI 63.6 to 88.9), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: mITT population included all randomized participants who had at least 1 post-baseline assessment of the primary efficacy parameter, the C-APPS, as described in the protocol. Overall number analyzed is the number of participants with data available for analyses.

Primary outcome: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)

Time frame: From the first dose of study drug up to end of study (up to Day 120). Count of participants. Unit: Participants

Measure	Placebo n = 56	BOTOX® Low Dose n = 59	BOTOX® High Dose n = 54
Value	13	14	14

Population analysed: Safety population included all participants who were administered study intervention.

Primary outcome: Pulse Rate at Baseline

Time frame: Baseline (Day 1). Mean (Standard Deviation). Unit: beats per minute (beats/min)

Measure	Placebo n = 56	BOTOX® Low Dose n = 59	BOTOX® High Dose n = 54
Value	73.0 (10.77)	74.4 (9.77)	73.6 (10.66)

Population analysed: Safety population included all participants who were administered study intervention.

Primary outcome: Change From Baseline in Pulse Rate at Day 7

Time frame: Baseline; Day 7. Mean (Standard Deviation). Unit: beats/min

Measure	Placebo n = 46	BOTOX® Low Dose n = 49	BOTOX® High Dose n = 46
Value	1.0 (8.19)	-0.5 (6.76)	1.2 (13.86)

Population analysed: Safety population included all participants who were administered study intervention. Overall number analyzed is the number of participants with data available for analyses.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All cause mortality is reported from enrollment to end of study; median time on follow up was 128.0, 127.0 and 129.0 days for placebo, BOTOX low dose and BOTOX high dose, respectively. TEAEs and SAEs were collected from first dose of study drug until 120 days after last dose of study drug; mean duration on study drug was 1 day for placebo, BOTOX low dose and BOTOX high dose, respectively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 56 (0%)	10 of 56 (17.9%)	0 of 57
BOTOX® Low Dose	2 of 59 (3.4%)	6 of 59 (10.2%)	0 of 59
BOTOX® High Dose	0 of 54 (0%)	8 of 54 (14.8%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41933889Humphrey S, Shimoga S, Kaufman J, Bank D, Biesman B, Harutunian C, West GS, Tong W, Patel V. Patient-Reported Outcomes After Treatment With OnabotulinumtoxinA for Platysma Prominence: Results From a Phase 2 Dose-Ranging Study. J Cosmet Dermatol. 2026 Apr;25(4):e70821. doi: 10.1111/jocd.70821.
Derived from this study: PubMed 40704633Garcia JK, Hopfinger RM, Foley C, Whyte J, Gauthier M, Foster B, Patel V. Development and validation of patient-reported outcome measures for platysma prominence. Curr Med Res Opin. 2025 Jul;41(7):1277-1290. doi: 10.1080/03007995.2025.2537898. Epub 2025 Jul 31.
Derived from this study: PubMed 38640068Rohrich RJ, Bertucci V, Dayan S, Jones D, Solish N, Rivers JK, Weiss RA, Muhn CY, Harutunian C, Park GS, Shimoga S, Lee E, Tong W. Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Platysma Prominence: A Randomized Phase 2 Dose-Ranging Study. Plast Reconstr Surg. 2025 Jan 1;155(1):79-88. doi: 10.1097/PRS.0000000000011472. Epub 2024 Apr 16.
Related InfoLink provided by the sponsor.
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.

ALLERGAN INC. study director

Allergan

12 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BOTOX® purified neurotoxin complex in people with Platysma Prominence, run by Allergan at 12 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 5 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 3 May 2023). 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?

Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS) (time frame: Day 14). The study lists 23 primary outcomes in all. 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 NCT03915067, which also lists 3 linked publications.

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 3 May 2023.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Publications

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (5 listed)

Key exclusion criteria (8 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS)

Primary outcome: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)

Primary outcome: Pulse Rate at Baseline

Primary outcome: Change From Baseline in Pulse Rate at Day 7

Adverse events

Research links

Related trials for Platysma Prominence

A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)

A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Percentage of Participants With at Least 1-Grade Improvement at Day 14 as Rated by Investigator Using the Clinician Allergan Platysma Prominence Scale (C-APPS)

Primary outcome: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Event (TEAE)

Primary outcome: Pulse Rate at Baseline

Primary outcome: Change From Baseline in Pulse Rate at Day 7

Adverse events