Masseter Muscle ProminencePhase 2NCT03861936

BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence

A Phase 2 study testing OnabotulinumtoxinA and Normal saline in people with Masseter Muscle Prominence, run by Allergan at 14 sites in United States.

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

Based on the results of the Phase 2 Study 191622-130 [NCT02010775], the current Phase 2b study is designed to further evaluate the safety and efficacy of BOTOX® for the treatment of Masseter Muscle Prominence (MMP) in adults. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Masseter Muscle Prominence
What is being tested?: OnabotulinumtoxinA and Normal saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 14 sitesUnited States
Study dates: 16 May 2019to 2 Jul 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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participant has bilateral MMP (identical grades for left and right masseter), as determined at the Day 1 visit by the investigator using the MMPS
Participant has bilateral MMP, as determined at the Day 1 visit by the participant using the Masseter Muscle Prominence Scale-Participant (MMPS-P)
Body mass index (BMI) ≤ 30 kilogram/square meter (kg/m^2) using the calculation: BMI = weight (kg) [height (m^2)]
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 contraceptive guidance during the treatment and follow-up period
Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits.

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
Any uncontrolled medical condition
An anticipated need for surgery or overnight hospitalization during the study
An anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
Prior mid-facial and/or lower facial treatment with nonpermanent soft tissue fillers, synthetic implantations, autologous fat transplantation, fat-reducing injectables, and/or skin-tightening laser treatments within 6 months of entry into the study

Show all 16Show fewer

Current or planned dental or facial procedures during the study period (eg, braces, dental implants, and reconstructive or aesthetic surgery) that could interfere with MMPS, as determined by the investigator
Facial hair or scarring (eg, acne) significant enough to interfere with the 3D clinical photography assessment
Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
Prior exposure to botulinum toxin of any serotype to the masseter muscle or lower face at any time, or to any other part of the body within the 6 months prior to Day 1
Current intraoral infection, including infection of the mouth or gums, or facial skin infection requiring medical treatment in the opinion of the investigator
History of or current Temporomandibular Joint Dysfunction (TMJD), or presence of signs/symptoms of possible TMJD, in the opinion of the investigator
Weakness of the masseter, pterygoid, or temporalis muscles due to trauma, facial nerve injury, or other condition that could interfere with normal chewing and jaw clenching, as determined by the investigator
Excess lower facial fat, loose or lax skin in lower face, or parotid gland prominence that could interfere with MMPS, as determined by the investigator
Significant asymmetry of left and right sides of the face that could prevent identical MMPS grading on both sides of the face, as determined by the investigator
Masseter prominence due to other etiologies (eg, parotid gland infection, parotiditis, malignancy) based upon findings from the oral examination.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

DermResearch, Inc.
Austin, Texas, 78759
Bellaire Dermatology Associates
Bellaire, Texas, 77401
Total Skin & Beauty Dermatology Center, PC
Birmingham, Alabama, 35205
DeNova Research
Chicago, Illinois, 60611
Westside Aesthetics
Los Angeles, California, 90025
Skin Care and Laser Physicians of Beverly Hills
Los Angeles, California, 90069
Baumann Cosmetic and Research Institute
Miami, Florida, 33137
Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, 37203
Etre, Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, 70130
Skin Specialists, PC
Omaha, Nebraska, 68144
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
Advanced Clinical Research Gateway Aesthetic Institute & Laser Center
Salt Lake City, Utah, 84101
Cosmetic Laser Dermatology
San Diego, California, 92121
Saint Louis University Dermatology
St Louis, Missouri, 63122

Other trials in United States

About this study

Official title: BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 2b, Multicenter, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study

Conditions: Masseter Muscle Prominence
Being tested: OnabotulinumtoxinA, Normal saline

What participants receive

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

OnabotulinumtoxinABiological
Also called BOTOX®, botulinum toxin Type A
OnabotulinumtoxinA (botulinum toxin Type A;BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1.
Normal salineDrug
Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles on Day 1.

Study groups in NCT03861936
Study group	Role	What they receive
BOTOX® 72U	Experimental	OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72 units (U) total dose administered intramuscularly to the bilateral masseter muscles on Day 1. Receives: Biological: OnabotulinumtoxinA
BOTOX® 48U	Experimental	OnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1. Receives: Biological: OnabotulinumtoxinA
Placebo	Placebo comparator	Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1. Receives: Drug: Normal saline

What is being measured

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

Percentage of Participants Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 at Day 90 as Assessed by the Investigator
The investigator assessed the severity of the participant's masseter muscle prominence (MMP) using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants where the investigator selected 1=minimal, 2=mild, or 3=moderate are reported.
Measured: Day 90
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is an AE that occurs or worsens after receiving study drug.
Measured: First dose (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Systolic Blood Pressure
Measured: Baseline (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Diastolic Blood Pressure
Measured: Baseline (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Respiratory Rate
Respiratory rate is calculated as number of breaths (inhalation and exhalation) in one minute.
Measured: Baseline (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Pulse Rate
Pulse rate measures the number of times your heart beats per minute.
Measured: Baseline (Day 1) to the End of Study (Up to Day 180) ]

Secondary outcomes (6)

Percentage of Participants Who Achieved Participant Masseter Muscle Prominence Scale-Participant (MMPS-P) Grade ≤ 3 at Day 90 as Assessed by the Participant
The participant assessed the severity of their MMP using the MMPS-P 5-point scale where: 1=not at all pronounced (best), 2=mildly pronounced, 3=moderately pronounced, 4=pronounced, and 5=very pronounced (worst). The percentage of participants who selected 1=not at all pronounced, 2=mildly pronounced, or 3=moderately pronounced are reported.
Measured: Day 90
Percentage of Participants Who Achieved ≥ 2-grade MMPS Improvement From Baseline at Day 90 as Assessed by the Investigator
The investigator assessed the severity of the participant's MMP using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants who achieved a ≥ 2-grade improvement (decrease) from Baseline as assessed by the investigator are reported.
Measured: Baseline (Day 1) to Day 90
Percentage of Participants Who Achieved ≥ 2-grade MMPS-P Improvement From Baseline at Day 90 as Assessed by the Participant
The participant assessed the severity of their MMP using the MMPS-P 5-point scale where: 1=not at all pronounced (best), 2=mildly pronounced, 3=moderately pronounced, 4=pronounced, and 5=very pronounced (worst). The percentage of participants who achieved a ≥ 2-grade improvement (decrease) from Baseline as assessed by the participant are reported.
Measured: Baseline (Day 1) to Day 90
Percentage of Participants Who Achieved Participant Self-Assessment of Change (PSAC) in MMP Grade ≥ 2 (at Least Moderately Improved From Baseline) at Day 90
The participants assessed the degree of change of their MMP using a single item composed of 7 grades (3 to -3) where: 3=much improved, 2=moderately improved, 1=minimally improved, 0=no change, -1=minimally worse, -2=moderately worse, and -3=much worse. The percentage of participants where the participant selected 2=moderately improved, or 3=much improved as compared to Baseline are reported.
Measured: Baseline (Day 1) to Day 90
Change From Baseline in Lower Facial Volume at Day 90 Using Landmark Area of Interest (AOI) Analysis
Lower facial volume was calculated from 3-dimensional (3D) surface images captured at Baseline and Day 90. The analysis region is defined using a series of anatomical landmarks placed on the baseline surface that are then projected mathematically to the posttreatment surface and verified by a technician. The difference in volume is measured between the select region of the baseline surface to the posttreatment surface. The lower facial volume is summed for both the left side and the right side of the face. An analysis of covariance (ANCOVA) model was used for analyses.
Measured: Baseline (Day 1) to Day 90
Change From Baseline in Lower Facial Volume at Day 90 Using Statistical MMP AOI Analysis
Lower facial volume was calculated from 3D surface models of the full area of the lower face captured at Baseline and Day 90. The statistical MMP AOI method is based on a statistical shape averaging of the area of change post masseter treatment from multiple facial models. The difference in volume is calculated between the two 3D surface models at Baseline and Day 90. An ANCOVA model was used for analyses.
Measured: Baseline (Day 1) to Day 90

Timeline

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

16 May 20192 Jul 2020

First posted5 Mar 2019
Study start16 May 2019
Primary completion3 Apr 2020
Study completion2 Jul 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.
Other trials for Masseter Muscle 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03861936
Sponsor's protocol ID: 1789-202-008
Status last verified: Apr 2021
First submitted: 25 Feb 2019
Last updated: 28 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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/.

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BOTOX® (onabotulinumtoxinA) Treatment of Masseter Muscle Prominence: A Phase 2b, Multicenter, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study
ClinicalTrials.gov ID: NCT03861936
Acronym / sponsor ID: 1789-202-008
Conditions: Masseter Muscle Prominence
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 16 May 2019 (actual)
Primary completion: 3 Apr 2020 (actual)
Study completion: 2 Jul 2020 (actual)
First posted: 5 Mar 2019 (actual)
Results: Posted 28 Apr 2021

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
BOTOX® 72U	Experimental	Biological: OnabotulinumtoxinAOnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 72 units (U) total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
BOTOX® 48U	Experimental	Biological: OnabotulinumtoxinAOnabotulinumtoxinA (botulinum toxin Type A; BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1.
Placebo	Placebo comparator	Drug: Normal salinePlacebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Participant has bilateral MMP (identical grades for left and right masseter), as determined at the Day 1 visit by the investigator using the MMPS
Participant has bilateral MMP, as determined at the Day 1 visit by the participant using the Masseter Muscle Prominence Scale-Participant (MMPS-P)
Body mass index (BMI) ≤ 30 kilogram/square meter (kg/m^2) using the calculation: BMI = weight (kg) [height (m^2)]
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:
Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits.

Key exclusion criteria (16 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
Any uncontrolled medical condition
An anticipated need for surgery or overnight hospitalization during the study
An anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
History of dental or surgical procedure for lower facial shaping or masseter muscle reduction

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: BOTOX®, botulinum toxin Type AOnabotulinumtoxinA (botulinum toxin Type A;BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1.	Biological	BOTOX® 48U, BOTOX® 72U
Normal salineNormal saline (placebo) administered intramuscularly to the bilateral masseter muscles on Day 1.	Drug	Placebo

Primary outcome

Percentage of Participants Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 at Day 90 as Assessed by the Investigator
Time frame: Day 90
The investigator assessed the severity of the participant's masseter muscle prominence (MMP) using the MMPS 5-point scale where: 1=minimal (best), 2=mild, 3=moderate, 4=marked, and 5=very marked (worst). The percentage of participants where the investigator selected 1=minimal, 2=mild, or 3=moderate are reported.
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: First dose (Day 1) to the End of Study (Up to Day 180)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is an AE that occurs or worsens after receiving study drug.
Change From Baseline in Systolic Blood Pressure
Time frame: Baseline (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Diastolic Blood Pressure
Time frame: Baseline (Day 1) to the End of Study (Up to Day 180)
Change From Baseline in Respiratory Rate
Time frame: Baseline (Day 1) to the End of Study (Up to Day 180)
Respiratory rate is calculated as number of breaths (inhalation and exhalation) in one minute.
Change From Baseline in Pulse Rate
Time frame: Baseline (Day 1) to the End of Study (Up to Day 180) ]
Pulse rate measures the number of times your heart beats per minute.

6 secondary outcomes

Percentage of Participants Who Achieved Participant Masseter Muscle Prominence Scale-Participant (MMPS-P) Grade ≤ 3 at Day 90 as Assessed by the Participant
Time frame: Day 90
Percentage of Participants Who Achieved ≥ 2-grade MMPS Improvement From Baseline at Day 90 as Assessed by the Investigator
Time frame: Baseline (Day 1) to Day 90
Percentage of Participants Who Achieved ≥ 2-grade MMPS-P Improvement From Baseline at Day 90 as Assessed by the Participant
Time frame: Baseline (Day 1) to Day 90
Percentage of Participants Who Achieved Participant Self-Assessment of Change (PSAC) in MMP Grade ≥ 2 (at Least Moderately Improved From Baseline) at Day 90
Time frame: Baseline (Day 1) to Day 90
Change From Baseline in Lower Facial Volume at Day 90 Using Landmark Area of Interest (AOI) Analysis
Time frame: Baseline (Day 1) to Day 90
Change From Baseline in Lower Facial Volume at Day 90 Using Statistical MMP AOI Analysis
Time frame: Baseline (Day 1) to Day 90

Results and safety

Results posted to the registry on 28 Apr 2021, 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	48	34
BOTOX® 48U	53	43
BOTOX® 72U	49	39

Primary outcome: Percentage of Participants Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 at Day 90 as Assessed by the Investigator

Time frame: Day 90. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo n = 46	BOTOX® 48U n = 53	BOTOX® 72U n = 46
Value	21.7 (9.8 to 33.7)	90.6 (82.7 to 98.4)	91.3 (83.2 to 99.4)

Placebo vs BOTOX® 48U: Percentage Difference: 68.8 (95% CI 54.5 to 83.1), p <.0001, Cochran-Mantel-Haenszel
Placebo vs BOTOX® 72U: Percentage Difference: 69.6 (95% CI 55.1 to 84.0), p <.0001, Cochran-Mantel-Haenszel

Population analysed: mITT Population consisted of all randomized participants who received study treatment and had at least 1 postbaseline MMPS assessment.

Primary outcome: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

Time frame: First dose (Day 1) to the End of Study (Up to Day 180). Count of participants. Unit: Participants

Measure	Placebo n = 48	BOTOX® 48U n = 53	BOTOX® 72U n = 49
Value	12	18	14

Population analysed: Safety Population consisted of all participants who received at least 1 injection of study intervention.

Primary outcome: Change From Baseline in Systolic Blood Pressure

Time frame: Baseline (Day 1) to the End of Study (Up to Day 180). Mean (Standard Deviation). Unit: millimeters of mercury (mmHg)

Measure	Placebo n = 48	BOTOX® 48U n = 53	BOTOX® 72U n = 49
Baseline	115.8 (13.52)	118.6 (10.39)	114.7 (13.64)
Change from Baseline to End of Study	-0.3 (10.09)	-1.2 (12.05)	-0.3 (10.82)

Population analysed: Safety Population consisted of all participants who received at least 1 injection of study intervention. Number analyzed is the number of participants with data available at the given time-point.

Primary outcome: Change From Baseline in Diastolic Blood Pressure

Time frame: Baseline (Day 1) to the End of Study (Up to Day 180). Mean (Standard Deviation). Unit: mmHg

Measure	Placebo n = 48	BOTOX® 48U n = 53	BOTOX® 72U n = 49
Baseline	76.8 (8.28)	77.7 (8.63)	76.6 (10.09)
Change from Baseline to End of Study	0.1 (6.72)	-0.2 (8.07)	0.8 (9.44)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose (Day 1) to the End of Study (Up to Day 180). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 48 (2.1%)	0 of 48 (0%)	0 of 48
BOTOX® 48U	1 of 53 (1.9%)	6 of 53 (11.3%)	0 of 53
BOTOX® 72U	0 of 49 (0%)	4 of 49 (8.2%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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/.

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.

Tanya Brandstetter study director

Allergan

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OnabotulinumtoxinA and Normal saline in people with Masseter Muscle Prominence, run by Allergan at 14 sites in United States.

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 7 inclusion and 16 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. 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 28 Apr 2021). 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 Who Achieved Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 at Day 90 as Assessed by the Investigator (time frame: Day 90). The study lists 6 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 NCT03861936.

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 28 Apr 2021.