Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A healthy, non-smoking male or female between the age of 22-65 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post last treatment
Awards & highlights
Study Summary
This trial studied a device to treat skin conditions using electricity to control bleeding and improve symptoms.
Who is the study for?
This trial is for healthy, non-smoking adults aged 22-65 with any skin type. Participants must not have severe sagging skin, recent Accutane use, or be on certain blood-thinning medications. They can't be in other trials, have specific electronic implants like pacemakers, metal implants that affect energy transmission, or allergies to adhesives or gold. Pregnant women and those not using birth control are excluded.Check my eligibility
What is being tested?
The study tests a RadioFrequency Microneedling Device called Potenza on various dermatologic conditions such as enlarged pores and acne scars. It aims to improve these conditions by electrocoagulation and hemostasis of soft tissues.See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, redness, swelling, bruising from microneedles entering the skin; risk of burns due to heat generated by radiofrequency; allergic reactions if sensitive to materials used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy, non-smoking individual aged between 22-65.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days post last treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post last treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
% of subjects satisfied with treatments.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Split-face treatmentExperimental Treatment1 Intervention
Subjects will receive split-face treatments where each side of the face may be treated with different tips.
Group II: General TreatmentExperimental Treatment1 Intervention
Subjects will receive treatment on the face, neck and/or body for conditions such as but not limited to wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks or loose skins.
Find a Location
Who is running the clinical trial?
Cynosure, Inc.Lead Sponsor
51 Previous Clinical Trials
1,216 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People with any skin type can participate.I am not pregnant, using effective birth control, or planning to become pregnant during the study.You are allergic to the numbing cream used before a procedure.You do not have sensitivity to heat in the treatment area or where the neutral pad is placed.I have a history of bleeding disorders.I understand this treatment is not for cosmetic purposes and have realistic expectations of the outcomes.I can attend all required visits for the trial.I have a heart device like an ICD or CRT.You have a metal implant that can disrupt the electric signals.You are allergic to gold.You are prone to developing keloids.You have loose or hanging skin in the treatment area, and the treatment may not work for you.I am currently taking aspirin, blood thinners, or anti-inflammatory medication.I have used Accutane between 6 to 12 months ago.I have had gold thread skin rejuvenation treatment.I have a cut, wound, or infection on the skin where treatment is planned.You have a pacemaker.You are allergic to medical tape or adhesives, and may experience a rash at the monitoring pad site.I am a healthy, non-smoking individual aged between 22-65.I have a condition like diabetes, epilepsy, or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Split-face treatment
- Group 2: General Treatment
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are younger individuals within the age range of 0-35 being considered for this research experiment?
"This clinical trial has an age restriction from 22 years and up to 65."
Answered by AI
Are there current opportunities to participate in this research?
"Affirmative. According to clinicaltrials.gov, this research is presently recruiting participants and was first publicized on July 24th 2023 before being revised in early August of the same year. The experiment needs approximately 20 individuals from one medical centre to participate."
Answered by AI
Are there eligibility criteria for prospective participants of this trial?
"Candidates aged between 22 and 65, with visible stretch marks can apply for this trial. 20 positions are available to qualified participants."
Answered by AI
How many individuals are participating in the trial at this point?
"Yes, according to information on clinicaltrials.gov this trial is presently recruiting patients. The investigation was first posted on July 24th 2023 and recently revised August 3rd 2023. This study requires the enrollment of twenty individuals across one site."
Answered by AI
Who else is applying?
What site did they apply to?
Cynosure, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger