Potenza Treatment for Skin Conditions

Overseen By Jamie Trimper

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cynosure, Inc.

Must not be taking: Photosensitizing drugs, Steroids, Accutane

Disqualifiers: Pregnancy, Cancer, Seizure disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this pilot study is exploratory investigation evaluating the Potenza microneedle fractional radiofrequency (RF) device and may be used in combination with the Icon intense pulsed light (IPL) device.

Eligibility Criteria

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.

Inclusion Criteria

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 skin issues like wrinkles, scars, or uneven skin tone that need treatment.

Exclusion Criteria

Is pregnant or of childbearing potential and not using (or willing to use) medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study

You are allergic to gold metal.

You have a pacemaker, defibrillator, or metal implants in your body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Potenza microneedle fractional radiofrequency (RF) treatments, with some also receiving Icon intense pulsed light (IPL) treatments

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with grading of skin aging and photodamage

90 days

Treatment Details

Interventions

• Icon
• Potenza

Trial Overview 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.

Participant Groups

Group I: Group B Experimental Treatment 2 Interventions

This group is Potenza and Icon treatments.

Group II: Group A Experimental Treatment 1 Intervention

This group is Potenza treatments only.

Who Is Running the Clinical Trial?

Cynosure, Inc.

Lead Sponsor

Trials

52

Recruited

1,200+