NCT05182502

Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Photodamage at Low Settings

A Prospective, Single-center, Single-arm Clinical Study Evaluating the Safety and Effectiveness of the Tixel Fractional System in the Treatment of Photodamage at Low Settings

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Eric Bernstein, MD · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To demonstrate the safety and performance of the Tixel fractional system for treatment of photodamage using low-energy settings.

Detailed description

A Prospective, single-center, single-arm clinical study of subjects who are seeking a procedure to reduce the appearance of photodamage, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. One investigational center will participate in the recruitment. Each study subject will receive 3 treatments with Tixel at 4-6 week intervals. Final follow-up will occur 3 months following the last treatment

Conditions

• Wrinkle

Interventions

Type	Name	Description
DEVICE	Tixel	Subjects will receive 3 monthly treatments with the Tixel device to treat the signs of photodamage

Timeline

• Start date: 2022-01-07
• Primary completion: 2023-09-01
• Completion: 2023-12-01
• First posted: 2022-01-10
• Last updated: 2022-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study