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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female subjects between 22 and 75 years of age.
Male or female subjects between 22 and 75 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study Summary
This trial tests a new way to reduce wrinkles on the cheeks, by first making small holes in the skin and then using a machine to smooth them out. Up to 70 people will be treated twice to see how well it works.
Who is the study for?
This trial is for men and women aged 22-75 with moderate to severe cheek wrinkles, rated at least a 3 on the Lemperle Wrinkle Scale. Participants must have Fitzpatrick skin type I to IV, use reliable birth control if applicable, and commit to the study schedule. Smokers, those with recent aesthetic treatments or certain medical conditions are excluded.Check my eligibility
What is being tested?
The Venus Aime procedure is being tested for its safety and effectiveness in reducing facial wrinkles. This involves mechanical coring of the skin followed by closure of cored areas. Up to 70 subjects will receive two treatments in this prospective study across up to four centers.See study design
What are the potential side effects?
Potential side effects may include discomfort at treatment sites, risk of infection, scarring or changes in skin pigmentation. There might also be reactions related to analgesics used during the procedure or materials involved in closing cored holes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 75 years old.
Select...
I am between 22 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of correct identification of photograph sets from baseline and Day 120
Secondary outcome measures
Assess aesthetic improvement using Global Aesthetic Improvement Scale
Assess subject satisfaction post-treatment using Subject Satisfaction Scale
Other outcome measures
Assess safety profile by recording adverse events
Assess subject's assessment of discomfort and pain using Visual Analogue Scale
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
All subjects will receive two coring treatments on the cheeks with the robotic coring device.
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Who is running the clinical trial?
Venus ConceptLead Sponsor
34 Previous Clinical Trials
1,272 Total Patients Enrolled
3 Trials studying Wrinkles
50 Patients Enrolled for Wrinkles
Matthew Gronski, PhDStudy DirectorVenus Concept
4 Previous Clinical Trials
200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your skin type is categorized as light to medium.I am using birth control and have a negative pregnancy test.I have a bleeding disorder or take medication that increases bleeding risk.I have non-cancerous skin conditions in the area that needs treatment.I am between 22 and 75 years old.Your skin type is fair to medium.The wrinkles on your cheeks are noticeable and scored at least a 3 on the Lemperle Wrinkle Scale by the person in charge of the study.You are currently smoking or have quit smoking within the past 3 months.I have a scar in the area that needs treatment.I have not had skin cancer or any related condition in the past 6 months.You are allergic or have a strong reaction to painkillers, Betadine, tumescent, Tegaderm, or tensioning tape that will be used in the study.I haven't had cosmetic skin treatments like fillers or Botox in the last 6 months.You have a history of developing raised, thick scars called keloids or hypertrophic scars.I have a condition that weakens my immune system or healing ability.I am between 22 and 75 years old.I have had an active or recurrent herpes infection in the last 6 months.I am using birth control and have a negative pregnancy test.I have not used tanning beds, creams, or had excessive sun exposure in the last 30 days.You are able and willing to comply with the treatment/follow-up schedule and requirements.I don't have silicone, tattoos, or non-removable body jewelry in the treatment area.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
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.
Wrinkles Patient Testimony for trial: Trial Name: NCT05091788 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment for this trial restricted to individuals 45 years or younger?
"Individuals who fall between the age of 22 and 75 are allowed to enroll in this trial."
Answered by AI
How many participants have opted to join this research endeavor?
"To successfully complete this trial, 70 eligible patients must be enrolled. The sponsor of the study is Venus Concept and two participating sites are DeNova Research in Chicago, Illinois and Menter Dermatology Research Institute based out of Dallas, Texas."
Answered by AI
What is the geographic scope of this clinical investigation?
"The medical trial is looking for participants from four different recruiting sites including DeNova Research (Chicago), Menter Dermatology Research Institute (Dallas), Dr. Brian Kinney's practice in Beverly Hills, and an assortment of additional healthcare facilities."
Answered by AI
Is the recruitment process ongoing for this trial?
"Per information found on clinicaltrials.gov, this health study is currently looking to enroll patients. The initial posting date was March 22nd 2022 and the latest update came in May 26th 2022."
Answered by AI
Do I meet the criteria to become a participant of this experiment?
"This clinical trial seeks 70 individuals with wrinkles in the age range of 22 to 75 years. To qualify, applicants must be either male or female, literate and willing to read and sign an informed consent form, women of childbearing potential should use contraception for 3 months before enrolment and have a negative urine pregnancy test at baseline. Additionally, they need to have Fitzpatrick skin type I - IV as determined by the investigator using Lemperle Wrinkle Scale (score ≥3). Lastly, participants are expected to follow treatment/follow-up instructions throughout the study period."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
Illinois
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Dr. Brian Kinney
Other
DeNova Research
Menter Dermatology Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
I will do anything to get rid of wrinkles. Would love to remove wrinkles from my face!!!
PatientReceived 2+ prior treatments
I currently use cosmetic treatments for wrinkles like Botox and fillers. Interesting work that you do so would like to see if it would work out for my skin.
PatientReceived 1 prior treatment
I have had a great deal of stress in the last few years and I worry it shows in my face.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long do screening visits take? Are there accommodations? Is there pay?
PatientReceived no prior treatments
1. How long do you expect the recovery period to be wherein I will probably not want to make any major engagements?
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- DeNova Research: < 24 hours
Average response time
- < 1 Day
Typically responds via
Phone Call
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