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A Safety and Effectiveness Study of the Tixel Device, (Fractional Peri-orbital Wrinkles Treatment ) Compared With Laser

NCT03454672 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-08-23

Study results available
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Summary

This study is designed to explore the safety and the effectiveness of the Tixel device. This device performs fractional treatment of the skin by applying thermal (heat) energy to the skin. The study shall compare the safety and the effectiveness of the Tixel with the safety and the effectiveness of a laser device which is currently cleared for marketing in the US.

Conditions

  • Wrinkle

Interventions

DEVICE

Tixel

Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.

DEVICE

Laser

Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.

Sponsors & Collaborators

  • Novoxel Ltd.

    lead INDUSTRY

Principal Investigators

  • Arielle NB Kauvar, M.D · New York Laser & Skin Care Clinic

  • Sharon Naim, B.Sc, · Novoxel Ltd.

  • Rafi Carasso, M.D · Hillel Yaffe Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-12
Primary Completion
2020-09-04
Completion
2020-09-04
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 NCT03454672 on ClinicalTrials.gov