NCT04639713

Clinical Study Evaluating the Safety and Effectiveness of The Tixel Fractional System in The Treatment of Periorbital Wrinkles

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Novoxel Ltd. · Industry
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

Summary

A Prospective, Multicenter, Single-Arm Clinical Study of 51 study subjects who are seeking a procedure to reduce the appearance of the peri-orbital wrinkles. Up to 5 investigational centers in Israel and the United States will participate in the recruitment. Each study subject will receive four (4) treatments with Tixel in a monthly interval. Follow-up will occur 1 month and 3 months following last treatment.

Detailed description

A Prospective, Multicenter, Single-Arm Clinical Study of 51 subjects who are seeking a procedure to reduce the appearance of the periorbital wrinkles, and meet study eligibility criteria, and have provided informed consent will be enrolled in the study. Up to 5 investigational centers in Israel and the United States will participate in the recruitment. Each study subject will receive 4 treatments with Tixel in a monthly interval. Follow-up will occur at 1 month and 3 months following the last treatment. The clinic visits will be as follow: 1. Baseline (1st tx) 2. Phone-call visit (3 days after the first treatment) 3. 4wk (2nd tx) 4. 8wk (3rd tx) 5. 12wk (4th tx) 6. 4 weeks after the last treatment (1st FU) 7. 12 weeks after the last treatment (2nd FU= 3 months FU, primary endpoint and study completion visit) Primary Efficacy Endpoint is the comparison of the proportion of subjects with a ≥ 1-score improvement on the FWCS at the 3-month visit compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. Primary Safety Endpoint is the evaluation of related adverse events up to the 3-month visit after treatment.

Conditions

• Wrinkle
• Periorbital
• Tixel 2
• Fractional
• Resurfacing

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: 2021-03-02
• Primary completion: 2022-04-04
• Completion: 2022-04-04
• First posted: 2020-11-20
• Last updated: 2024-03-19
• Results posted: 2024-03-19

Locations

3 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated device study