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

50 Participants Needed

Trial Summary

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 data supports the idea that Energy-Based Devices for Skin Conditions is an effective treatment?

The available research shows that Energy-Based Devices, like radiofrequency (RF) and combined RF light technologies, are effective for improving skin conditions. They are used for skin tightening, wrinkle reduction, and skin rejuvenation. For example, the Pelleve procedure, which uses RF energy, is noted for reducing facial wrinkles and tightening skin without pain or downtime. Additionally, RF microneedling is highlighted as a safe and effective option for various skin concerns, making it a popular choice for those who prefer non-surgical treatments. These devices are effective across different skin types and offer a non-invasive alternative to more traditional methods. ^{1 2 3 4 5}

What safety data exists for energy-based skin treatments?

Research indicates that energy-based devices, including radiofrequency microneedling and combined RF light technologies, are generally safe and effective for various skin conditions. Studies highlight minimal risks, even for darker skin types, and emphasize the importance of optimizing treatment parameters for safety and efficacy. Devices like Morpheus8 and Renesis have been noted for their unique technological advances and safety profiles in treating aesthetic and dermatological concerns. ^{1 4 5 6 7}

Is the treatment in the trial 'Energy-Based Devices for Skin Conditions' promising?

Yes, the treatment is promising because it uses radiofrequency (RF) microneedling, which is safe and effective for improving skin conditions. It helps with skin tightening, lifting, and reducing acne scars, and works well for all skin types. This makes it a popular choice for people who want to improve their skin without surgery. ^{2 4 5 6 8}

What is the purpose of this trial?

The goal of the energy-based devices used in this study is to evaluate their safety and performance to treat unwanted dermatologic conditions.

Research Team

Sean Doherty

Principal Investigator

Cynosure, LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Exploring channeling optimized radiofrequency energy: a review of radiofrequency history and applications in esthetic fields. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Radiofrequency Microneedling in the Facial Plastic Surgeon's Practice: A Review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Bipolar fractional radiofrequency treatment induces neoelastogenesis and neocollagenesis. [2018]

8. Japan pubmed.ncbi.nlm.nih.gov

The aesthetic applications of intense pulsed light using the Lumenis M-22 device. [2021]