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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.

Wrinkle Clinical Trial

Official title:
A Prospective, 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, 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05282979
Study type Interventional
Source Physicians Laser and Dermatology Institute
Contact Megan Calderon
Phone 3122800890
Email megan@pldilaser.com
Status Recruiting
Phase N/A
Start date August 20, 2021
Completion date August 20, 2022
View Details
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