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

NCT04639713 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-03-19

Study results available
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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.

Conditions

  • Wrinkle
  • Periorbital
  • Tixel 2
  • Fractional
  • Resurfacing

Interventions

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.

Sponsors & Collaborators

  • Novoxel Ltd.

    lead INDUSTRY

Principal Investigators

  • Jerome M Garden, MD · Physicians Laser and Dermatology Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2022-04-04
Completion
2022-04-04
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04639713 on ClinicalTrials.gov