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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
Must not have
Presence of an active systemic or local skin disease or condition that may affect wound healing or interfere with participation
History of collagen, vascular or immunosuppressive or deficiency disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post last treatment
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any skin conditions that could affect wound healing.
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I have a history of immune system or connective tissue disorders.
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I have a history of keloids or my wounds heal poorly.
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I am on medication that makes my skin more sensitive to sunlight.
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I have been treated with gold therapy.
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I am willing and able to follow all study requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days post last treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post last treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Grading of Skin Aging and Photodamage

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Cynosure, Inc.Lead Sponsor
51 Previous Clinical Trials
1,216 Total Patients Enrolled

Media Library

Potenza (Microneedle Fractional Radiofrequency Device) Clinical Trial Eligibility Overview. Trial Name: NCT05847530 — N/A
Scarring Research Study Groups: Group A, Group B
Scarring Clinical Trial 2023: Potenza Highlights & Side Effects. Trial Name: NCT05847530 — N/A
Potenza (Microneedle Fractional Radiofrequency Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05847530 — N/A
~5 spots leftby Jan 2025
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