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Microneedle Fractional Radiofrequency Device
Potenza Treatment for Skin Conditions
N/A
Recruiting
Research Sponsored by Cynosure, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post last treatment
Awards & highlights
Study Summary
This trial is exploring if a combination of needles and light can improve skin conditions.
Who is the study for?
This trial is for healthy adults over 18 with unwanted skin conditions like wrinkles, stretch marks, scarring, or pigmentation. Participants must not plan other treatments in the affected areas during the study and should avoid weight loss. They can't join if they have cancer, skin diseases affecting healing, recent cosmetic procedures in target areas, sensitivity to light or gold metal allergies.Check my eligibility
What is being tested?
The Potenza microneedle fractional RF device is being tested for its effectiveness on various skin conditions. It may be used alongside the Icon IPL device. The goal is to see how well these treatments improve cosmetic dermatologic issues.See study design
What are the potential side effects?
Potential side effects could include temporary redness, swelling at the treatment site, discomfort during application, minor bleeding from microneedles and possible bruising. There might also be a risk of infection or pigment changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days post last treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 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
Grading of Skin Aging and Photodamage
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment2 Interventions
This group is Potenza and Icon treatments.
Group II: Group AExperimental Treatment1 Intervention
This group is Potenza treatments only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Potenza
2019
N/A
~90
Icon
2021
N/A
~50
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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:- You are allergic to gold metal.You have a pacemaker, defibrillator, or metal implants in your body.Your skin is sensitive to light.I don't have skin conditions or allergies that could affect cancer treatment.I do not have any skin conditions that could affect wound healing.I have not taken steroids in the last 2 weeks.I have a blood clotting disorder or have taken blood thinners in the last 2 weeks.I agree not to have any procedures or aim for weight loss in the treated areas during the study.I can follow all study rules and visit schedules.I have not used Accutane in the last year.You have seizures that are triggered by flashing lights.I haven't had surgery or cosmetic procedures in the area to be treated in the last 6-12 months.I have a history of immune system or connective tissue disorders.I have a history of keloids or my wounds heal poorly.I am on medication that makes my skin more sensitive to sunlight.You have a mental health condition, or you abuse alcohol or drugs.I have skin issues like wrinkles, scars, or uneven skin tone that need treatment.I am 18 years or older and in good health.I have been treated with gold therapy.I am willing and able to follow all study requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
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 there any open positions in this clinical exploration?
"The most recent edits to clinicaltrials.gov indicate that this medical trial, which was posted on May 1st 2023, is not currently looking for participants. However, there are 120 other studies searching for volunteers right now."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Scripps Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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