Energy-Based Devices for Skin Conditions

JT
Overseen ByJamie Trimper
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.16789

Who Is on the Research Team?

About Sean Doherty, MD | Board ...

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.
See 2 more

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
See 18 more

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?
4Treatment groups
Experimental Treatment
Group I: RF OnlyExperimental Treatment1 Intervention
Group II: RF Microneedling OnlyExperimental Treatment1 Intervention
Group III: IPL onlyExperimental Treatment1 Intervention
Group IV: CombinationExperimental Treatment4 Interventions

Find a Clinic Near You

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

Citations

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, ...
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.
The Latest Trends in Laser and Energy-Based DermatologyThe newer devices now offer effective collagen and elastin stimulation with minimal discomfort or downtime. This evolution mirrors “K-Beauty” ...
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 ...
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.
Q&A: FDA warns of radiofrequency microneedling risksThe FDA recently warned the public of serious complications from radiofrequency microneedling device use. Healio spoke with a dermatologist ...
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 ...
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 ...
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, ...
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