NCT05282979

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.

A Prospective, Single-arm Clinical Study Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Periorbital Wrinkles

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Physicians Laser and Dermatology Institute · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Accepted

Summary

A Prospective, Single center, Single-Arm Clinical Study of 13-20 study participants who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles. Each study participant will receive up to four (4) treatments with the Tixel in a monthly interval. Follow-up will occur 1 month and 3 months following last treatment.

Detailed description

A Prospective, Single center, Single-Arm Clinical Study of 13-20 participants who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. Each study participate will receive up to 4 treatments with Tixel in monthly interval. Follow-up will occur at 1 month and 3 months following the last visit. The clinic visits will be as follow: 1. Base line (1st tx) 2. Phone-call visit (3 days after the first treatment) 3. 4 week (2nd tx) 4. 8 week (3rd tx) 5. 12 week (4th tx) 6. 4 weeks after the last treatment (1st Follow-up) 7. 12 weeks after the last treatment (2nd follow-up = 3 months follow-up, primary endpoint and the study completion visit) Primary Safety Endpoint is the evaluation of related adverse events up to the 3-month visit after treatment.

Conditions

• Wrinkle

Interventions

Type	Name	Description
DEVICE	Tixel 2	Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide dermal remodeling and collagen restructuring that promote wrinkles appearance improvement.

Timeline

• Start date: 2021-08-20
• Primary completion: 2022-08-20
• Completion: 2022-08-20
• First posted: 2022-03-16
• Last updated: 2022-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study