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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare different energy-based devices for skin rejuvenation, focusing on their effectiveness and side effects. The treatments target areas such as the face, neck, hands, trunk, limbs, and vagina. It suits adults noticing signs of skin aging who wish to explore rejuvenation options. Participants must be able to consent and should not have significant medical conditions affecting the skin or blood.

As an unphased trial, this study provides a unique opportunity to explore various rejuvenation treatments without the constraints of traditional clinical trial phases.

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 prior data suggests that these energy devices are safe for skin rejuvenation?

Research has shown that devices like Fraxel Restore, Helios III, PicoWay, Halo, ThermiVa, and DiVa are safe and effective for improving skin appearance. These devices are available and have been proven safe. For example, Fraxel Restore uses gentle technology suitable for all skin types.

Studies have found that these lasers can reduce signs of aging, such as wrinkles and uneven skin tone. Safety data indicates that these treatments are generally safe when used correctly. However, mild side effects like redness or swelling may occur but usually resolve on their own.

In summary, these devices are commonly used and considered safe for rejuvenating skin appearance. It is important to consult a doctor about any concerns or questions before starting treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional options like topical creams or invasive surgical procedures for skin rejuvenation, energy devices are turning heads because they use advanced technology to refresh and revitalize the skin. These devices, including Fraxel Restore and PicoWay, harness specific types of energy, like lasers and radiofrequency, to target the deeper layers of the skin, promoting collagen production and improving texture. This method can address multiple areas of the body and deliver noticeable results with minimal downtime, making it an appealing alternative to more conventional, time-consuming treatments. Researchers are excited because this approach could provide a faster, less invasive way to achieve youthful-looking skin.

What evidence suggests that these energy devices are effective for skin rejuvenation?

Research has shown that devices like lasers and LEDs (light-emitting diodes) effectively improve skin appearance by reducing wrinkles and sagging. In this trial, participants will receive energy-based treatments such as Fraxel Restore, Helios III, PicoWay, Halo, ThermiVa, or DiVa, based on the investigators' assessment. Studies have found that fractional picosecond lasers help with signs of facial aging, such as large pores, uneven skin tone, and wrinkles. Another study on fractional laser resurfacing showed that these treatments can tighten skin by boosting the production of new collagen, a protein that gives skin its structure. Treatments like the Fraxel laser have demonstrated significant improvements in skin rejuvenation, although results can vary. Overall, these devices have proven effective for rejuvenating skin on different parts of the body. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

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

I am either male or female.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-1-2018-cc60e

Energy Devices for Skin Rejuvenation · Info for Participants Research shows that energy devices, like lasers and light-emitting diodes (LEDs), are effective in improving skin appearance by reducing wrinkles and sagging.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9852188/

An update on fractional picosecond laser treatment It has been shown that fractional picosecond laser has a positive effect on facial photoaging, enlarged facial pores, dyspigmentation, wrinkles, and atrophic ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.16514

Advancements in laser technologies for skin rejuvenation ... This comprehensive analysis seeks to evaluate recent advancements in laser technology for skin rejuvenation, focusing on efficacy, safety, and patient ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7028380/

Fractional Laser Resurfacing Treats Photoaging by Promoting ... CONCLUSION: At three months after laser resurfacing, skin lifting in photoaged skin likely resulted from new collagen deposition but also from edema. Keywords: ...

5. researchgate.net researchgate.net/publication/24250522_Rejuvenation_of_the_Aging_Face_Using_Fraxel_Laser_Treatment

Rejuvenation of the Aging Face Using Fraxel Laser Treatment Data confirm that improvement with this treatment is substantial but is not yet well defined quantitatively in comparison with laser resurfacing. ResearchGate ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf6/K063808.pdf

Fraxel IV SR Laser System and Accessories Clinical Performance Data. Sufficient safety data has been gathered to determine that the Fraxel IV Laser System and. Accessories performs as clinically ...

7. dratencio.com dratencio.com/faq-guide-fraxel-restore-laser-skin-rejuvenation-in-austin/

FAQ Guide: Fraxel Restore Laser Skin Rejuvenation in Austin Fraxel Restore is a safe and effective option for skin rejuvenation across all skin types and colors, thanks to its non-ablative fractional technology and ...

8. academic.oup.com academic.oup.com/asj/article/25/3/307/228307

Rejuvenation of the Aging Face Using Fraxel Laser Treatment Conceptually, this seems to be a safe, desirable approach to treating photodamaged skin. This rapidly evolving technology is claimed to produce a clearly ...