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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for skin conditions such as wrinkles, scars, and uneven skin tone. It tests the Potenza microneedle device alone and in combination with the Icon light device. The trial aims to evaluate the effectiveness of these treatments in improving skin appearance. Individuals with unwanted skin issues, such as facial wrinkles or acne scars, who can commit to study requirements may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance skin appearance.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, such as anticoagulants and steroids, at least 2 weeks before the study. If you're taking medication that increases sensitivity to sunlight, you may also need to stop. It's best to discuss your specific medications with the study team.

What prior data suggests that the Potenza microneedle fractional radiofrequency (RF) device and Icon intense pulsed light (IPL) device are safe for skin conditions?

Research shows that the Potenza microneedling device is generally safe. Studies have found that microneedling usually has very few negative effects, making it a safe choice for many people. Potenza features a special tip that enhances skin treatment.

The Icon laser system, well-respected in the cosmetic field, is trusted by both new and experienced users, suggesting its safety. Although detailed safety information on using Potenza with the Icon device together is lacking, each device has a good safety record individually.

Participants should consider any possible risks and consult healthcare providers before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for skin conditions, which often involve topical creams or oral medications, Potenza is a radiofrequency microneedling device that combines two technologies to rejuvenate the skin. This method targets both the surface and deeper layers of the skin, potentially offering more comprehensive results. Researchers are particularly excited about Potenza's ability to stimulate collagen production, which could lead to improved skin texture and firmness with potentially fewer side effects. Additionally, in one of the treatment groups, Potenza is combined with Icon, a light-based treatment, which aims to enhance the rejuvenating effects further by addressing pigmentation and vascular issues.

What evidence suggests that this trial's treatments could be effective for skin conditions?

Research has shown that the Potenza microneedle fractional radiofrequency (RF) device effectively addresses various skin issues. Studies have found it can increase collagen production by 400%, improving skin texture and reducing signs of aging. It also reduces acne scars and minimizes pores by controlling oil production. In this trial, participants in Group A will receive only Potenza treatments, while Group B will receive a combination of Potenza and Icon treatments. When used with the Icon intense pulsed light (IPL) device, reports indicate significant improvements in skin problems. This combination treatment reduced non-inflammatory skin issues by up to 54% and inflammatory ones by up to 58%. These findings suggest that Potenza, alone or with Icon, could be a promising option for improving skin health. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. finance.yahoo.com finance.yahoo.com/news/400-collagen-boost-insights-reveal-133400037.html

400% Collagen Boost? Insights Reveal Potenza Fusion ... RL&A's findings underscore the efficacy of the Potenza Fusion Tip in boosting results, backed by compelling data from clinical studies: 400 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05847530/pilot-evaluation-of-the-cynosure-potenzatm-system-for-treatment-of-cosmetic-dermatologic-skin-conditions

Pilot Evaluation of the Cynosure Potenza™ System for ... The primary objective of this pilot study is exploratory investigation evaluating the Potenza microneedle fractional radiofrequency (RF) ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/57/NCT05097157/Prot_SAP_000.pdf

protocol #: cyn19-rf-mn-01 The first risk identified is the efficacy of the treatment. There is a lack of clinical data for evidence of effectiveness when treating with the Potenza™ ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7869810/

A Systematic Review Examining the Potential Adverse ... RESULTS: In this systematic review, a total of 51 articles were reviewed, which included 1,029 patients who received microneedling procedures ...

5. ctv.veeva.com ctv.veeva.com/study/prospective-clinical-study-to-assess-safety-and-to-collect-data-on-radiofrequency-microneedling-devi

Prospective Clinical Study to Assess Safety and to Collect ... The goal of the Radiofrequency microneedling devices (Potenza and Morpheus) used in this study is to collect clinical data for dermatologic ...

6. assets.greenbook.net assets.greenbook.net/13-44-35-19-07-2017-Potenza_MSDS4.pdf

SAFETY DATA SHEET POTENZA® - Greenbook.net Personal Precautions: Avoid inhalation of vapors and spray mist and contact with skin and eyes. Ensure adequate ventilation. Wear suitable protective clothing.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05847530

NCT05847530 | Pilot Evaluation of the Cynosure Potenza ... Also called a data safety and monitoring board ... Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05254210

Feasibility Study To Collect Safety And Preliminary Efficacy ... The intended use of the Potenza™ device is to collect clinical data for brow lifting and/or treatment of dermatologic conditions in which electrocoagulation ...

9. cynosure.com cynosure.com/product/potenza/

Potenza RF Microneedling System The Potenza device is a highly versatile RF microneedling platform featuring the revolutionary Fusion Tip for enhanced topical penetration.