25 Participants Needed

Tixel for Photodamage (Wrinkles)

EF
KL
Overseen ByKachiu Lee, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.16789

Who Is on the Research Team?

EF

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.
See 5 more

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.
See 24 more

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?
1Treatment groups
Experimental Treatment
Group I: Tixel treatment armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eric Bernstein, MD

Lead Sponsor

Trials
1
Recruited
30+

Novoxel Ltd.

Industry Sponsor

Trials
9
Recruited
370+

Citations

Open-label study assessing the efficacy and tolerability of topical skincare and sun protection products following intense pulsed light treatment. [2018]
Treatment of photodamaged facial skin with topical tretinoin. [2019]
Side effects and complications of fractional laser photothermolysis: experience with 961 treatments. [2008]
Clinical experience with the Fraxel SR laser: 202 treatments in 59 consecutive patients. [2021]
A review of tazarotene in the treatment of photodamaged skin. [2021]
Interventions for photodamaged skin. [2018]
Wrinkles. [2018]
Wrinkles. [2021]
Photodynamic photorejuvenation. [2019]
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