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Clinical Study To Evaluate Paired Treatment With An Alexandrite Laser And Radiofrequency Microneedling For Facial Aging

NCT05388604 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-10-18

No results posted yet for this study

Summary

The intended use of the radiofrequency and microneedling devices used in this study is to assess the efficacy and safety of paired treatment for the treatment of facial aging.

Conditions

  • Wrinkle
  • Photoaging
  • Dyschromia

Interventions

DEVICE

RF device

The entire defined treatment area will then be treated by delivering adjacent pulses with minimal overlap of 10% or less. Parameters may be adjusted throughout the treatment in order to increase subject comfort.

DEVICE

Microneedling device

Test spots may be performed prior to the first treatment. Test spots may be performed prior to the first treatment. It will follow a similar procedure to treatment but only in an inconspicuous place, such as behind the ear, in an area no larger than 2in x 2in. The tip will be placed in contact with the skin, and parameters may be adjusted throughout the treatment and will determined by the Clinician.

Sponsors & Collaborators

  • Cynosure, Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer Civiok · Director of Clinical Development

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2023-08-29
Completion
2023-08-29
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 NCT05388604 on ClinicalTrials.gov