A Prospective, Single Center, Single-Arm Clinical Study of 20 Participants to Reduce the Appearance of the Peri-orbital Wrinkles. Participants Will Receive up to Four Treatments With Tixel Every 4 Weeks. Follow-up Will Occur 1 Month and 3 Months Following Last Treatment.

Overseen By Jerome Garden, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Physicians Laser and Dermatology Institute

Must not be taking: Oral retinoids, Oral steroids

Disqualifiers: Pregnancy, Skin malignancy, Diabetes, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves using the Tixel device to treat people with wrinkles around their eyes. The device gently heats the skin to encourage it to repair itself, which helps to smooth out wrinkles. Participants will receive up to four treatments, with follow-ups in the months after the last treatment. 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 taking your current medications. However, if you are using medications that affect the skin in the treatment area or have taken certain medications like oral retinoids or long-term oral steroids recently, you may need to stop or avoid them. It's best to discuss your specific medications with the trial team.

Research Team

Jerome Garden, M.D.

Principal Investigator

Physician Laser & Dermatology Institute

Eligibility Criteria

Inclusion Criteria

Fitzpatrick wrinkle score of 3-7 in the peri-orbital areas per the treating investigator.

Stable body weight during the study period.

Skin Type I - V as per Fitzpatrick Skin Scale

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants receive up to four treatments with Tixel every 4 weeks

12 weeks

4 visits (in-person), 1 phone-call visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person)

Treatment Details

Interventions

• Tixel 2

Participant Groups

Group I: Tixel 2 Experimental Treatment 1 Intervention

Tixel 2 Treatment, 4 treatment sessions, followed by 2 Follow up sessions, 1 and 3 months after last treatment visit. Subject would be questioned about pain level, subjective downtime assessment and subjective response assessment. Images would be taken at the baseline and in Follow up visits.

Who Is Running the Clinical Trial?

Physicians Laser and Dermatology Institute

Lead Sponsor

Trials

1

Recruited

20+