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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post treatment follow-up visit
Awards & highlights
Study Summary
This trial tests a new treatment using patients as their own controls in multiple locations. Results are evaluated anonymously.
Eligible Conditions
- Cellulite
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post treatment follow-up visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post treatment follow-up visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure
Trial Design
1Treatment groups
Experimental Treatment
Group I: CelluliteExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sofwave
2020
Completed Phase 3
~240
Find a Location
Who is running the clinical trial?
Sofwave Medical LTDLead Sponsor
9 Previous Clinical Trials
512 Total Patients Enrolled
1 Trials studying Cellulite
69 Patients Enrolled for Cellulite
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of skin disorders that affect the collagen or blood vessels in your body.You smoke a lot, at least 25 cigarettes a day, or have smoked heavily in the last 10 years.You have a body mass index (BMI) of 30 or higher, which means you are overweight or obese.You are currently taking medication for mental health conditions.You want to get rid of cellulite on your upper thighs and/or buttocks.You have a history of severe migraines.You have a history of long-term drug or alcohol abuse.You have a history of bleeding problems or are taking medication that could make you more likely to bruise.You have a medical condition that could delay healing or weaken your immune system, like a blood disorder or inflammatory disease.You have allergies to lidocaine, epinephrine, or antibiotics.You have a history of serious issues with your lymphatic system.You have skin problems like infections, rashes, or scarring in the area where the treatment will be applied.You have a tattoo or previous tattoo near the area where the treatment will be given.You have noticeable scarring or a history of scars that heal poorly, and you easily get bruises.You have visible dimples or bumps on your thighs or buttocks.You are currently using or have used diet pills or weight control supplements in the last month.You have a history of seizures or epilepsy.You have a history of blood clotting disorders or are taking medication to prevent blood clots.
Research Study Groups:
This trial has the following groups:- Group 1: Cellulite
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Cellulite Patient Testimony for trial: Trial Name: NCT05882721 — N/A
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 have an age restriction for participants?
"This experiment is seeking individuals who are aged 18 and above, but not yet 60 years old."
Answered by AI
Do I meet the qualifications for participation in this experiment?
"The requirements for entry into this medical trial are cellulite and an age of between 18-60. At the present, around 60 individuals need to be recruited."
Answered by AI
Are there any available slots for individuals to partake in this experiment?
"Yes, the information hosted on clinicaltrials.gov affirms that this medical investigation is currently recruiting participants. The study was initially posted on February 20th of 2023 and has since been revised as late as May 22nd of 2023 - with a need for 60 patients from 5 separate trial sites."
Answered by AI
How many medical facilities are currently administering this trial?
"Currently, this trial is taking place at 5 different sites. These include the cities of Hackensack and New york as well as Ardmore and two other urban centres. To limit commute times, it would be prudent to select a nearby location when signing up for the study."
Answered by AI
How many participants are participating in this clinical experiment?
"This clinical trial necessitates the enrollment of 60 suitable candidates. Patients can sign up at Schweiger Dermatology GP Research in Hackensack, NJ or UnionDerm in New york City."
Answered by AI
Who else is applying?
What state do they live in?
Texas
New Jersey
Virginia
Other
What site did they apply to?
Schweiger Dermatology GP Research
UnionDerm
Other
Tennessee Clinical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
1
0
Why did patients apply to this trial?
My cellulite effects my life and mental health. I hate my cellulite and am looking for anything to help!!
PatientReceived 1 prior treatment
I have tried multiple treatments and nothing is providing results. I'm hoping this clinical trial will help with the cellulite removal.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long are the visits and how many visits? How long does the visits take? How often are the visits?
PatientReceived no prior treatments
What is the process like? Do you trial both legs front and back? How many on site visits are required? How long are the visits? How long is the study?
PatientReceived 1 prior treatment
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