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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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. The study involves people who want to reduce their photodamage and will receive multiple treatments over a period of time. The goal is to see if this low-energy heat treatment can safely make their skin look better. Treating facial and scalp actinic keratoses with the Tixel device was found to be effective and safe.

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 data supports the effectiveness of the treatment Tixel for photodamage (wrinkles)?

While there is no direct data on Tixel, similar treatments like fractional lasers and intense pulsed light (IPL) have shown effectiveness in improving photodamage, including wrinkles. Additionally, topical retinoids such as tretinoin and tazarotene have been proven to significantly reduce signs of photodamage. ^{1 2 3 4 5}

How is the Tixel treatment different from other treatments for wrinkles caused by photodamage?

Tixel is unique because it uses a thermal-mechanical action to treat wrinkles, which is different from other treatments like topical retinoids or intense pulsed light (IPL) that rely on chemical or light-based methods. This approach may offer a novel way to improve skin texture and reduce wrinkles without the need for chemicals or lasers. ^{5 6 7 8 9}

Research Team

Eric F. Bernstein, MD

Principal Investigator

Main Line Center for Laser Surgery

Eligibility Criteria

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

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

Treatment Details

Interventions

• Tixel

Participant Groups

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+

References

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

Open-label study assessing the efficacy and tolerability of topical skincare and sun protection products following intense pulsed light treatment. [2018]

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

Treatment of photodamaged facial skin with topical tretinoin. [2019]

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

Side effects and complications of fractional laser photothermolysis: experience with 961 treatments. [2008]

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

Clinical experience with the Fraxel SR laser: 202 treatments in 59 consecutive patients. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A review of tazarotene in the treatment of photodamaged skin. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Interventions for photodamaged skin. [2018]

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

Wrinkles. [2018]

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

Wrinkles. [2021]

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

Photodynamic photorejuvenation. [2019]