Energy-Based Devices for Skin Conditions

Overseen By Jamie Trimper

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cynosure, Inc.

Must not be taking: Isotretinoin, Systemic steroids, Gold therapy, others

Disqualifiers: Pregnancy, Infections, Seizure disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Varies by group, with at least 30 days between treatments if enrolling in multiple groups

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of various energy-based devices for treating unwanted skin conditions. Participants may receive treatments using intense pulsed light (IPL), radiofrequency (RF), or RF microneedling devices. Some groups will use a combination of these devices to evaluate their combined effects. The trial seeks healthy adults willing to try these devices and commit to attending all study visits. As an unphased trial, participants can explore innovative treatments and contribute to advancing skin care solutions.

Do I need to stop my current medications for the trial?

The trial requires you to stop taking certain medications. You cannot participate if you have taken oral isotretinoin in the last six months, are using systemic steroids, or are taking medications that alter wound healing. If you are on these medications, you will need to stop them to join the trial.

What prior data suggests that these energy-based devices are safe for treating skin conditions?

A previous study found intense pulsed light (IPL) safe for treating skin issues like unwanted pigment and signs of aging. However, some risks exist. Reports include burns, blisters, scarring, and skin discoloration, especially if the treatment is not performed correctly.

Research has shown that radiofrequency (RF) devices are generally well-tolerated and can safely and effectively tighten skin. In rare cases, though, they can cause burns, scarring, and other issues if misused.

RF microneedling devices carry more serious risks. Reports mention burns, scarring, fat loss, and nerve damage, which can sometimes require surgery to repair.

When combined in some treatments, studies have shown these devices are generally safe for different skin types. Still, careful use is crucial to avoid problems. Treatments should always be performed by trained professionals to reduce risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these energy-based treatments for skin conditions because they offer unique ways to rejuvenate the skin compared to traditional methods like topical creams or chemical peels. Intense pulsed light (IPL) devices target pigments and blood vessels, which can help with issues like redness and dark spots. Radiofrequency (RF) devices, including RF microneedling, use heat to stimulate collagen production deep in the skin, potentially improving firmness and texture without the downtime of surgery. The combination treatments are particularly promising as they integrate multiple technologies, aiming to provide more comprehensive skin improvements by addressing various skin layers and concerns simultaneously. This multi-faceted approach could deliver faster, more noticeable results, sparking enthusiasm among researchers and dermatologists.

What evidence suggests that this trial's energy-based devices could be effective for treating unwanted skin conditions?

Research shows that intense pulsed light (IPL) therapy, which participants in the IPL-only arm of this trial may receive, effectively improves skin texture and reduces pigmentation issues like sunspots and freckles caused by sun exposure. Studies have found that IPL can help reverse signs of skin aging and sun damage. Participants in the RF-only arm will receive treatments with radiofrequency (RF) devices, proven to be safe and effective for rejuvenating skin by boosting collagen, a protein that keeps skin firm. The RF Microneedling-only arm will involve RF microneedling, which combines RF energy with tiny needles to treat various skin conditions, offering noticeable improvements with less recovery time than traditional methods. The Combination arm will explore the use of combined energy devices, enhancing skin quality and improving issues like acne scars and body shape. Overall, strong evidence supports the effectiveness of these treatments in addressing unwanted skin conditions. ^{1 6 7 8 9}

Who Is on the Research Team?

Sean Doherty

Principal Investigator

Cynosure, LLC

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 22 or older who are willing to undergo at least one skin treatment with the study devices and can commit to all study visits without undergoing other procedures in the area during the trial. Pregnant women, recent Accutane users, those with certain medical implants, steroid use, healing issues, infections, light-triggered seizure disorders or allergies to adhesives cannot participate.

Inclusion Criteria

I am willing to try at least one treatment with the study device.

I can attend all required appointments.

I am 22 years old or older and healthy.

Exclusion Criteria

You are allergic to numbing creams or gels used on the skin.

I have an infection or an open wound in the area that needs treatment.

Has any condition or is in a situation which in the investigator's opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with energy-based devices, including IPL, RF, and RF microneedling, to evaluate safety and performance

Varies by group, with at least 30 days between treatments if enrolling in multiple groups

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Combined energy devices
• Intense pulsed light
• Radiofrequency device
• Radiofrequency microneedling device

Trial Overview The study tests safety and performance of various energy-based devices like combined energy devices, radiofrequency microneedling device, radiofrequency device and intense pulsed light for treating unwanted skin conditions.

How Is the Trial Designed?

Group I: RF Only Experimental Treatment 1 Intervention

Group C will be treated with an RF device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar RF device that is cleared for use by the FDA.

Group II: RF Microneedling Only Experimental Treatment 1 Intervention

Group B will be treated with a radiofrequency (RF) microneedling device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar RF microneedling device that is cleared for use by the FDA.

Group III: IPL only Experimental Treatment 1 Intervention

Group A will be treated with an intense pulsed light (IPL) device only. They may also receive split treatments where one side of the face and/or body will be treated with the study device and the contralateral side will be treated with a similar IPL device that is cleared for use by the FDA.

Group IV: Combination Experimental Treatment 4 Interventions

Group D will receive combination treatments and will be treated with 2 or more of the study devices.

Who Is Running the Clinical Trial?

Cynosure, Inc.

Lead Sponsor

Trials

52

Recruited

1,200+

Published Research Related to This Trial

Radiofrequency (RF) energy is a safe and effective method for aesthetic treatments such as cellulite reduction, body contouring, and skin tightening, with a study showing an average improvement of 55% in cellulite appearance among 27 female patients.

The RF treatments not only improved skin appearance but also enhanced blood circulation and collagen remodeling, with results sustained over time and minimal side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring channeling optimized radiofrequency energy: a review of radiofrequency history and applications in esthetic fields. Belenky, I., Margulis, A., Elman, M., et al.[2019]

Radiofrequency microneedling (RFM) enhances skin rejuvenation with minimal downtime and safety, allowing for more aggressive treatments compared to older RF devices.

RFM has been effective in treating various skin conditions, including acne scarring, skin laxity, and hyperhidrosis, with low risks even for individuals with darker skin types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency Microneedling: Overview of Technology, Advantages, Differences in Devices, Studies, and Indications. Weiner, SF.[2020]

In a study involving 92 patients treated with the MP-22 Intense Pulsed Light device, 93% reported satisfaction with their treatment for benign skin lesions, indicating high efficacy for conditions like lentigo and superficial vascular lesions.

The treatment was found to be safe, with only minor side effects such as temporary erythema and facial edema reported, and no major complications like scarring or pigmentation changes observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The aesthetic applications of intense pulsed light using the Lumenis M-22 device. Ullmann, Y., Elkhatib, R., Fodor, L.[2021]

Radiofrequency (RF) microneedling, particularly with the Morpheus8 device, is a safe and effective treatment for various skin conditions across all skin types.

Morpheus8 stands out among similar devices due to its unique technological advancements, making it a preferred choice for practitioners seeking minimally invasive skin rejuvenation options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Radiofrequency Microneedling in the Facial Plastic Surgeon's Practice: A Review. Magro, I., Kochhar, A., Arnaoutakis, D., et al.[2022]

In a study involving 11 women, a single-session treatment combining intense pulsed light (IPL), infrared light, and diode laser with bipolar radiofrequency (RF) showed significant improvements in photoaged skin, including reduced signs of aging and enhanced skin elasticity.

The treatment resulted in measurable increases in collagen and elastin levels, indicating its efficacy in addressing multiple skin concerns like tone, texture, and laxity without requiring additional recovery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination treatment using bipolar radiofrequency-based intense pulsed light, infrared light and diode laser enhanced clinical effectiveness and histological dermal remodeling in Asian photoaged skin. Kim, JE., Chang, S., Won, CH., et al.[2022]

Radiofrequency (RF) technologies are proven to be safe and effective for various dermatological treatments, including skin tightening and wrinkle reduction.

Recent advances in RF and combined RF light/laser technologies enhance their clinical applications in aesthetic medicine, making them versatile options for procedures like acne scarring and hair removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The radiofrequency frontier: a review of radiofrequency and combined radiofrequency pulsed-light technology in aesthetic medicine. Sadick, N., Sorhaindo, L.[2022]

The Renesis radiofrequency device effectively initiates a vigorous wound healing response in human skin, leading to significant increases in collagen and elastin content over a 10-week period, indicating its potential for treating skin laxity and wrinkles.

Histological and molecular analyses showed that the treatment promotes neoelastogenesis and neocollagenesis, with key proteins like HSP47 playing a crucial role in the dermal remodeling process following the fractional RF treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bipolar fractional radiofrequency treatment induces neoelastogenesis and neocollagenesis. Hantash, BM., Ubeid, AA., Chang, H., et al.[2018]

The Pelleve Procedure uses continuous monopolar radiofrequency energy to safely heat the skin, resulting in noticeable cosmetic improvements without pain or downtime, making it a convenient option for patients.

This method contrasts with traditional pulsed heating techniques, allowing for more effective and uniform skin contraction across treated areas, which enhances the overall results of nonablative skin treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pelleve procedure: an effective method for facial wrinkle reduction and skin tightening. Stampar, M.[2011]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11189641/

Energy-Based Devices for the Treatment of Facial Skin ... There are numerous available studies demonstrating safety and efficacy of energy-based devices for the treatment of facial skin conditions in skin types III-VI, ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/jocd.16407

Combinations of Energy‐based Devices plus isotretinoin ... Evidence-based treatments such as PDL, NAFL, and FMRF etc. are suggested relatively safe and effective in treating acne and acne scarring.

3. dermatologytimes.com dermatologytimes.com/view/the-latest-trends-in-laser-and-energy-based-dermatology

The Latest Trends in Laser and Energy-Based Dermatology The newer devices now offer effective collagen and elastin stimulation with minimal discomfort or downtime. This evolution mirrors “K-Beauty” ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10087797/

Effectiveness of combined use of targeted pressure energy ... Results showed high patient satisfaction and efficacy in improving body contour and skin quality. Combining simultaneous HIFEM+RF procedure with simultaneous ...

5. nextstepsinderm.com nextstepsinderm.com/derm-topics/expert-insights-lasers-and-energy-based-devices-to-treat-pigmentary-disorders/

Expert Insights | Lasers and Energy-Based Devices to ... Dr. Gilly Munavalli shares how lasers & energy-based devices can help treat pigmentary disorders when used safely.

6. healio.com healio.com/news/dermatology/20251103/qa-fda-warns-of-radiofrequency-microneedling-risks-heres-what-to-know

Q&A: FDA warns of radiofrequency microneedling risks The FDA recently warned the public of serious complications from radiofrequency microneedling device use. Healio spoke with a dermatologist ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06111482

Clinical Study to Evaluate Different Energy-based Devices ... The goal of the energy-based devices used in this study is to evaluate their safety and performance to treat unwanted dermatologic conditions. Detailed ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12287879/

Integrating VYC‐12L With Energy‐Based Devices for Skin ... Multimodal treatment using VYC‐12L and EBDs together can provide a more comprehensive, tailored approach to skin‐quality improvement, delivering ...

9. ajmc.com ajmc.com/view/gaps-remain-in-research-on-laser-energy-based-device-safety-for-skin-of-color-arielle-kauvar-md

Gaps Remain in Research on Laser, Energy-Based Device ... When lasers or other kinds of energy devices are first developed, for safety reasons, they're always tested on lighter skin tones. After that, ...