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

Wrinkle Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04639713
Study type Interventional
Source Novoxel Ltd.
Contact
Status Completed
Phase N/A
Start date March 2, 2021
Completion date April 4, 2022
View Details
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