Platysma ProminencePhase 2PAOLANCT05773053
A Study of NT 201 Doses in the Treatment of Platysma Prominence
A Phase 2 study testing NT 201 in people with Platysma Prominence, run by Merz Aesthetics GmbH at 7 sites in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of NT 201 in adults with moderate to severe platysma prominence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Platysma Prominence
- What is being tested?
- NT 201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 Mar 2023to 24 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of four (medial and lateral, left and right) prominent platysmal bands
- Moderate to severe platysmal bands as assessed by the investigator and subject on the MAPS-D at maximum contraction
Who cannot join
- Any serious disease or disorder (medical or psychiatric) that could interfere with the safe completion of treatment or compromise subject safety
- Botulinum toxin treatment in the face (below the lower orbital rim), neck, or chest within the last 12 months prior to study treatment
- History of lower face surgery, neck or chest surgery, aesthetic procedures (e.g., ablative skin resurfacing, laser, chemical peel, micro-focused ultrasound, deoxycholic acid injections, micro-needling, non-surgical fat reduction procedure), and orthodontic procedures (e.g., braces) in the 12 months prior to study treatment
- Previous use of any permanent (non-biodegradable) or semi-permanent (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethyl methacrylate, etc.) facial tissue augmentation therapy, lifting sutures, permanent implants or autologous fat to the lower face (i.e., below the level of the bottom of the nose), neck, or chest within 24 months prior to study treatment
- Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy to the lower face (i.e., below the level of the bottom of the nose), neck, or chest within 12 months prior to study treatment
- Any medical condition that may put the subject at increased risk with exposure to botulinum toxin of any serotype, including myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function
- Female of childbearing potential not using a highly effective method of birth control, planning to get pregnant, or pregnant or lactating
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Merz Investigational Site #0010453
Aventura, Florida, 33180
Merz Investigation Site #0010470
Coral Gables, Florida, 33143
Merz Investigation Site #0010105
Metairie, Louisiana, 70006
Merz Investigation Site #0010469
New York, New York, 10022
Merz Investigation Site #0010405
New York, New York, 10028
Merz Investigation Site #0010471
Verona, New Jersey, 07044
Merz Investigation Site #0010170
Washington D.C., District of Columbia, 20037
About this study
Official title: A Prospective, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of NT 201 Doses in the Treatment of Platysma Prominence
The purpose of this study is to assess the safety and efficacy of NT 201 in adults with moderate to severe platysma prominence.
- Conditions
- Platysma Prominence
- Being tested
- NT 201, NT 201 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT 201Drug
Also called IncobotulinumtoxinA, Xeomin/Bocouture, Xeomin Cosmetic, Xeomeen
Clostridium botulinum neurotoxin type A (150 kiloDalton [kD], free of complexing proteins) powder for solution for injection.
NT 201 PlaceboDrug
NT 201 Matching-placebo.
| Study group | Role | What they receive |
|---|---|---|
| NT 201 Dose 1 | Experimental | Subjects will receive Dose 1. Receives: Drug: NT 201 |
| NT 201 Dose 2 | Experimental | Subjects will receive Dose 2. Receives: Drug: NT 201 |
| NT 201 Dose 3 | Experimental | Subjects will receive Dose 3. Receives: Drug: NT 201 |
| Placebo | Placebo comparator | Subjects will receive matching placebo. Receives: Drug: NT 201 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Investigator at Visit 4 (V4)
The platysma area will be assessed live by the investigator at maximum contraction and graded according to the validated five-point Merz Aesthetic Platysma Scale-Dynamic (MAPS-D). Scores range from Grade 1 (none to minimal) to Grade 5 (very severe).
Measured: Baseline (Screening Visit), Week 2 (V4)
Secondary outcomes (2)
Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Subject at V4
The platysma area will be assessed by the subjects at maximum contraction and graded according to the validated five-point MAPS-D. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe).
Measured: Baseline (Screening Visit), Week 2 (V4)
Number of Subjects With Related Treatment Emergent Adverse Events (Related TEAEs)
TEAEs are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment. An AE is considered to be related if a causal relationship between NT 201 and the AE is at least reasonably possible.
Measured: Baseline up to Week 17/End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start22 Mar 2023
- Primary completion19 Oct 2023
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Aesthetics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773053
- Sponsor's protocol ID
- M602011078
- Acronym
- PAOLA
- Status last verified
- Oct 2024
- First submitted
- 6 Mar 2023
- Last updated
- 21 Oct 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of NT 201 Doses in the Treatment of Platysma Prominence
- ClinicalTrials.gov ID
- NCT05773053
- Acronym / sponsor ID
- PAOLA / M602011078
- Conditions
- Platysma Prominence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Merz Aesthetics GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
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 this study is to assess the safety and efficacy of NT 201 in adults with moderate to severe platysma prominence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NT 201 Dose 1 | Experimental | Drug: NT 201Subjects will receive Dose 1. |
| NT 201 Dose 2 | Experimental | Drug: NT 201Subjects will receive Dose 2. |
| NT 201 Dose 3 | Experimental | Drug: NT 201Subjects will receive Dose 3. |
| Placebo | Placebo comparator | Drug: NT 201 PlaceboSubjects will receive matching placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of four (medial and lateral, left and right) prominent platysmal bands
- Moderate to severe platysmal bands as assessed by the investigator and subject on the MAPS-D at maximum contraction
Key exclusion criteria (7 listed)
- Any serious disease or disorder (medical or psychiatric) that could interfere with the safe completion of treatment or compromise subject safety
- Botulinum toxin treatment in the face (below the lower orbital rim), neck, or chest within the last 12 months prior to study treatment
- History of lower face surgery, neck or chest surgery, aesthetic procedures (e.g., ablative skin resurfacing, laser, chemical peel, micro-focused ultrasound, deoxycholic acid injections, micro-needling, non-surgical fat reduction procedure), and orthodontic procedures (e.g., braces) in the 12 months prior to study treatment
- Previous use of any permanent (non-biodegradable) or semi-permanent (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethyl methacrylate, etc.) facial tissue augmentation therapy, lifting sutures, permanent implants or autologous fat to the lower face (i.e., below the level of the bottom of the nose), neck, or chest within 24 months prior to study treatment
- Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy to the lower face (i.e., below the level of the bottom of the nose), neck, or chest within 12 months prior to study treatment
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 |
|---|---|---|
| NT 201Also: IncobotulinumtoxinA, Xeomin/Bocouture, Xeomin Cosmetic, XeomeenClostridium botulinum neurotoxin type A (150 kiloDalton [kD], free of complexing proteins) powder for solution for injection. | Drug | NT 201 Dose 1, NT 201 Dose 2, NT 201 Dose 3 |
| NT 201 PlaceboNT 201 Matching-placebo. | Drug | Placebo |
Primary outcome
Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Investigator at Visit 4 (V4)
Time frame: Baseline (Screening Visit), Week 2 (V4)
The platysma area will be assessed live by the investigator at maximum contraction and graded according to the validated five-point Merz Aesthetic Platysma Scale-Dynamic (MAPS-D). Scores range from Grade 1 (none to minimal) to Grade 5 (very severe).
2 secondary outcomes
Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Subject at V4
Time frame: Baseline (Screening Visit), Week 2 (V4)
Number of Subjects With Related Treatment Emergent Adverse Events (Related TEAEs)
Time frame: Baseline up to Week 17/End of Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
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.
Merz Medical Expert study director
Merz North America, Inc.
7 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 NT 201 in people with Platysma Prominence, run by Merz Aesthetics GmbH at 7 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 2 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Investigator at Visit 4 (V4) (time frame: Baseline (Screening Visit), Week 2 (V4)). 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 21 Oct 2024.