Tixel for Photodamage (Wrinkles)

Overseen By Kachiu Lee, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Eric Bernstein, MD

Must not be taking: Oral retinoids, Corticosteroids, Amiodarone, others

Disqualifiers: Pregnancy, Active infections, Diabetes, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12-18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Tixel for sun-induced skin damage, often appearing as wrinkles. The goal is to determine if Tixel is safe and effective at low energy settings. Participants will receive three monthly treatments to enhance their skin's appearance. Ideal candidates have noticeable sun-related skin damage and wrinkles, have not undergone certain cosmetic procedures in the past three months, and are willing to adhere to study requirements. As an unphased trial, this study provides a unique opportunity to explore innovative skin treatments and contribute to advancing dermatological research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you've used certain skin treatments or medications affecting skin sensitivity within 30 days, or oral retinoids in the past six months. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Tixel device is safe for treating photodamage?

Research has shown that the Tixel device is generally safe for skin treatments. Studies have found it effective on all skin types and usable with or without numbing cream, indicating minimal pain. Importantly, Tixel emits no radiation, so eye protection is unnecessary during use. Additionally, data indicate that Tixel 2, an updated version of the device, is as safe as other similar devices, suggesting it is well-tolerated by most people. Overall, these findings suggest that Tixel is safe for treating wrinkles and sun damage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Tixel is unique because it uses a novel thermal mechanical action to treat wrinkles and photodamage. Unlike traditional treatments like laser therapy, which can require significant downtime, Tixel offers a gentler approach with minimal recovery time. Researchers are excited about Tixel because it can precisely deliver controlled heat to the skin, promoting collagen production and skin rejuvenation without causing extensive damage to the surrounding tissue. This innovative delivery method could provide an effective and less invasive option for individuals seeking to improve skin texture and reduce wrinkles.

What evidence suggests that the Tixel device is effective for treating photodamage?

Studies have shown that Tixel effectively treats various skin issues, including wrinkles and sun damage. Tixel uses gentle heat to refresh the skin by encouraging natural healing. Research indicates that it can enhance facial skin appearance and help with conditions like wrinkles, rosacea, and acne. In one published study, Tixel successfully improved skin texture and reduced signs of aging. These results suggest that Tixel offers a promising option for treating sun damage and wrinkles. ^{1 2 3 4 6}

Who Is on the Research Team?

Eric F. Bernstein, MD

Principal Investigator

Main Line Center for Laser Surgery

Are You a Good Fit for This Trial?

Inclusion Criteria

You have noticeable wrinkles in the area being treated and a wrinkle score of 3-7 according to the doctor.

You are between 25 and 70 years old and have visible skin damage caused by sun exposure.

Your skin type is within the range of Type I to V according to the Fitzpatrick Skin Scale.

Exclusion Criteria

You have had filler injections in your cheeks, temples, or upper face area within the past 3 months.

You have had or currently have a type of cancer that affects the skin, especially on your face.

You have a condition that affects your connective tissues or causes problems with bleeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 treatments with the Tixel device at 4-6 week intervals

12-18 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tixel

How Is the Trial Designed?

Group I: Tixel treatment arm Experimental Treatment 1 Intervention

subjects will receive 3 monthly treatments with the Tixel device

Who Is Running the Clinical Trial?

Eric Bernstein, MD

Lead Sponsor

Trials

1

Recruited

30+

Novoxel Ltd.

Industry Sponsor

Trials

9

Recruited

370+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03454672

A Safety and Effectiveness Study of the Tixel Device ... This study is designed to explore the safety and the effectiveness of the Tixel device. This device performs fractional treatment of the skin by applying ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10911265/

Comprehensive Review of Thermomechanical Fractional ... Tixel is a novel energy-based device with promising results for a variety of dermatologic conditions as demonstrated by the studies included in this review.

3. withpower.com withpower.com/trial/phase-2022-689a1

Tixel for Photodamage (Wrinkles) · Info for Participants This trial is testing the safety and effectiveness of the Tixel fractional system, a device that uses gentle heat to improve skin damaged by sunlight.

4. crstodayeurope.com crstodayeurope.com/articles/2020-june/tixel-for-crows-feet-wrinkles-and-dry-eye-disease/

Tixel for Crow's Feet, Wrinkles, and Dry Eye Disease Published clinical study results show Tixel's ability to rejuvenate facial skin 1 and treat rosacea, active acne, hemangioma, hypertrophic scars, and more.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05182502

Study Details | NCT05182502 | Evaluating the Safety and ... Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Photodamage at Low Settings ; ClinicalTrials.gov ID NCT05182502.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K223033.pdf

June 21, 2023 Novoxel Ltd. Janice Hogan Partner Hogan ... Performance data demonstrate that the Tixel 2 is as safe and effective as the predicate device. Therefore, the Tixel. 2 is substantially ...