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Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device

NCT05096247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-11-28

Study results available
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Summary

The intended use of the RF (radiofrequency) device used in this study is to assess the efficacy of the handpiece for the treatment of facial wrinkles. If the other device (Intense Pulsed Light) laser in this study is used, the intended use will be for the treatment of benign pigmented and/or vascular lesions.

Conditions

  • Wrinkle
  • Benign Pigmented Lesions
  • Benign Vascular Lesions

Interventions

DEVICE

TempSure

This device is an RF device.

DEVICE

Icon

This device works with IPL (Intense Pulsed Light) handpieces.

Sponsors & Collaborators

  • Cynosure, Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer Civiok · Cynosure, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-03
Primary Completion
2022-09-13
Completion
2022-09-13
FDA Device
Yes

Countries

  • United States

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 NCT05096247 on ClinicalTrials.gov