Energy Devices for Skin Rejuvenation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Must not be taking: Blood thinners

Disqualifiers: Children, Skin disorders, Blood coagulopathies, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Varies based on treatment

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Non-ablative and ablative devices are the most commonly used minimally-invasive treatments for skin rejuvenation. Current devices on the market for rejuvenation include the lasers such as the Fraxel Restore, the Halo, the Helios III, the Pico, the ThermiVa and the DiVa which have all been shown to have efficacy for the rejuvenation of the face, décolletage, hands and vagina. In this study we propose to compare the efficacy and side effect profile of these devices for skin rejuvenation of various areas of the body including the face, décolletage, hands, trunk, upper and lower extremities, and vagina.

Will I have to stop taking my current medications?

If you are taking any medications that affect blood clotting, like aspirin or fish oil, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Energy Devices for Rejuvenation?

Research shows that energy devices, like lasers and light-emitting diodes (LEDs), are effective in improving skin appearance by reducing wrinkles and sagging. Additionally, combining these devices with other treatments, such as hyaluronic acid, enhances skin rejuvenation. ^{1 2 3 4 5}

Is the use of energy devices for skin rejuvenation generally safe?

Energy devices like intense pulsed light, laser diodes, radiofrequency, and light-emitting diodes have been found to have favorable safety profiles with few significant adverse events in clinical trials. However, some reports of adverse events like skin damage and scarring exist, and more research is needed to fully understand their safety. ^{6 7 8 9 10}

How does the Energy Devices for Rejuvenation treatment differ from other skin rejuvenation treatments?

The Energy Devices for Rejuvenation treatment is unique because it uses advanced energy-based technologies like bipolar fractionated radiofrequency (RF) and light-emitting diode (LED) devices, which are designed to improve skin appearance by promoting skin renewal and addressing issues like wrinkles and sagging without the need for invasive procedures. ^{3 9 11 12 13}

Eligibility Criteria

This trial is for people aged 18-85 who show signs of skin aging and could benefit from non-surgical skin rejuvenation treatments. It's open to all genders with certain skin types (I-III for some devices, I-VI for others). Participants must understand the study and agree to follow its rules.

Inclusion Criteria

My skin shows signs of aging and I need treatment for rejuvenation as advised by my doctor.

I am either male or female.

Subjects must be able and willing to give written informed consent and to comply with the requirements of this protocol. Consent form provided in English or translated if needed

Exclusion Criteria

I am taking medication that affects blood clotting.

I am under 18 years old.

I am willing and able to provide written consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive energy-based treatments using devices such as Fraxel Restore, Helios III, PicoWay, Halo, ThermiVa, or DiVa based on the physician's assessment

Varies based on treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment using the Global Aesthetic Improvement Scale

3 months

Treatment Details

Interventions

• Energy Devices for Rejuvenation

Trial Overview The study is comparing different energy-based devices like Fraxel Restore, Halo, Helios III, Pico, ThermiVa, and DiVa. These are used to refresh the appearance of various body parts including face, neck/décolletage, hands, trunk and genitals by treating the skin without cutting it.

Participant Groups

Group I: Rejuvenation Experimental Treatment 1 Intervention

Adults requiring rejuvenation of either the face, neck/décolletage, hands, upper and lower extremities, trunk and/or vagina will receive energy-based treatment (Fraxel Restore, Helios III, PicoWay, Halo, ThermiVa or DiVa) based on the investigators' assessment and discretion. The treating physician will decide which energy-based device is best-suited to addressing the patients' aging concerns; although patient preference will be taken into account, ultimately the treating physician will be responsible for the correct assessment of patients' rejuvenation needs and use of appropriate energy-based devices for the final treatment.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Findings from Research

A systematic review of 37 clinical trials found that home-based devices like intense pulsed light and laser diodes are effective for treating conditions such as hair removal and androgenic alopecia, respectively.

All evaluated devices demonstrated favorable safety profiles with minimal significant adverse events, although there is limited long-term data on their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based devices in dermatology: a systematic review of safety and efficacy. Cohen, M., Austin, E., Masub, N., et al.[2022]

LED-based devices are emerging as safe and effective tools for treating various skin and hair disorders, including inflammation and aging.

Despite their growing use in dermatology, more controlled studies are necessary to further confirm the efficacy of LED therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic and photobiological effects of light-emitting diode (LED) therapy in dermatological disease: an update. Sorbellini, E., Rucco, M., Rinaldi, F.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of hybrid energy and trifractional technologies in the treatment of acne scars: An open-label clinical trial. [2017]

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

Laser therapy in black skin. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Synergistic effects of using novel home-use 660- and 850-nm light-emitting diode mask in combination with hyaluronic acid ampoule on photoaged Asian skin: A prospective, controlled study. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Histological evidence for skin rejuvenation using a combination of pneumatic energy, broadband light, and growth factor therapy. [2010]

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

Ultrasound-Assisted Rhytidectomy Including Sub-SMAS and Subplatysmal Dissection. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Home-based devices in dermatology: a systematic review of safety and efficacy. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A review of the FDA's 510(k) approvals process for electromagnetic devices used in body contouring. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Guidelines on the safety of light-based home-use hair removal devices from the European Society for Laser Dermatology. [2012]

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

Our approach to non-ablative treatment of photoaging. [2005]

10. England pubmed.ncbi.nlm.nih.gov

Photodynamic and photobiological effects of light-emitting diode (LED) therapy in dermatological disease: an update. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Assessment of safety and efficacy of a bipolar fractionated radiofrequency device in the treatment of photodamaged skin. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Improvement of skin texture and wrinkles using radiofrequency ultra-thin electrode technology. [2020]

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

Evaluating, Purchasing, and Incorporating High-Tech Equipment into a Facial Plastic Surgery Practice. [2021]