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NT 201 for Neck Wrinkles (PAOLA Trial)
PAOLA Trial Summary
This trial evaluates a new medication to help reduce neck wrinkles in adults with moderate to severe cases.
PAOLA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPAOLA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 256 Patients • NCT02270736PAOLA Trial Design
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Who is running the clinical trial?
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- You have a medical condition that could make it risky for you to receive botulinum toxin, like myasthenia gravis or amyotrophic lateral sclerosis, which affect how your muscles work.Your neck muscles have noticeable bands when you tighten them, as determined by the doctor and yourself during an examination.You have a serious medical or psychiatric condition that could make it unsafe for you to complete the treatment or could put your safety at risk.You have noticeable bands in your neck muscles on both sides.You have received botulinum toxin treatment on your face, neck, or chest in the past year.
- Group 1: NT 201 Dose 2
- Group 2: NT 201 Dose 1
- Group 3: NT 201 Dose 3
- Group 4: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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