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Neurotoxin

NT 201 for Neck Wrinkles (PAOLA Trial)

Phase 2
Waitlist Available
Research Sponsored by Merz Aesthetics GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (screening visit), week 2 (v4)
Awards & highlights

PAOLA Trial Summary

This trial evaluates a new medication to help reduce neck wrinkles in adults with moderate to severe cases.

Who is the study for?
This trial is for adults with moderate to severe platysmal bands, which are prominent neck muscles. Candidates must not have had certain facial surgeries or aesthetic procedures in the past year, no use of permanent face augmentation within 24 months, and no botulinum toxin treatments in the face or neck area within the last year. Women must be using effective birth control if of childbearing potential.Check my eligibility
What is being tested?
The study tests NT 201 against a placebo to see how safe and effective it is at treating platysma prominence (visible neck muscle bands). Participants will receive either NT 201 or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with similar treatments include injection site reactions like pain and swelling, muscle weakness near where the drug was injected, headache, and possibly allergic reactions.

PAOLA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have noticeable bands in your neck muscles on both sides.
Select...
Your neck muscles have noticeable bands when you tighten them, as determined by the doctor and yourself during an examination.

PAOLA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (screening visit), week 2 (v4)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (screening visit), week 2 (v4) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Investigator at Visit 4 (V4)
Secondary outcome measures
Change From Baseline on the MAPS-D Score at Maximum Contraction as Assessed by the Subject at V4
Number of Subjects With Related Treatment Emergent Adverse Events (Related TEAEs)

Side effects data

From 2019 Phase 3 trial • 256 Patients • NCT02270736
12%
Respiratory tract infection viral
9%
Pharyngitis
9%
Respiratory tract infection
9%
Rhinitis
6%
Viral infection
3%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLEX: NT 201 (Age 2 to 5 Years)
Double-blind MP: Placebo (Age 6 to 17 Years)
Double-blind, MP: NT 201 (Age 6 to 17 Years)
Open-label, MP: NT 201 (Age 2 to 5 Years)
OLEX: NT 201 (Age 6 to 17 Years)

PAOLA Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: NT 201 Dose 3Experimental Treatment1 Intervention
Subjects will receive Dose 3.
Group II: NT 201 Dose 2Experimental Treatment1 Intervention
Subjects will receive Dose 2.
Group III: NT 201 Dose 1Experimental Treatment1 Intervention
Subjects will receive Dose 1.
Group IV: PlaceboPlacebo Group1 Intervention
Subjects will receive matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NT 201
2015
Completed Phase 4
~1380

Find a Location

Who is running the clinical trial?

Merz Aesthetics GmbHLead Sponsor
2 Previous Clinical Trials
358 Total Patients Enrolled
Merz Medical ExpertStudy DirectorMerz North America, Inc.
38 Previous Clinical Trials
7,039 Total Patients Enrolled

Media Library

NT 201 (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05773053 — Phase 2
Platysmal Bands Research Study Groups: NT 201 Dose 2, NT 201 Dose 1, NT 201 Dose 3, Placebo
Platysmal Bands Clinical Trial 2023: NT 201 Highlights & Side Effects. Trial Name: NCT05773053 — Phase 2
NT 201 (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05773053 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accept elderly individuals as participants?

"Per the outlined conditions for participation, applicants must fall within an age range of 18 and 65 to be eligible."

Answered by AI

To what demographic is this research open?

"The clinical trial is accepting 68 patients afflicted with platysmal bands, who are between 18 and 65 years old."

Answered by AI

Is there still an opportunity for individuals to participate in this research?

"Per the details listed on clinicaltrials.gov, this medical trial is actively enrolling individuals. The first posting was made on March 22nd 2023 and updated one day later."

Answered by AI

What is the scope of recruitment for this medical experiment?

"To initiate the study, Merz Aesthetics GmbH requires 68 individuals that meet all of their inclusionary criteria. These patients must come from two locations managed by Merz: Investigational Site #0010453 in Aventura, Florida and Investigation Site #0010470 in Coral Gables, New york."

Answered by AI

How many geographical hotspots is this study taking place in?

"This clinical trial has 4 distinct recruiting sites, including Merz Investigational Site #0010453 in Aventura, Merz Investigation Site #0010470 in Coral Gables and Merz Investigation Site #0010469 in New york. Other locations are currently available as well."

Answered by AI

Has the FDA approved NT 201 Dose 2 for use?

"Thanks to the preliminary data collected in Phase 2 trials, our team at Power judged NT 201 Dose 2's safety level as a '2' on our scale. There is some evidence supporting its efficacy but not enough for definitive conclusions."

Answered by AI
~34 spots leftby Mar 2025