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Feasibility Study To Collect Safety And Preliminary Efficacy Data For A Radiofrequency Microneedling Device

NCT05254210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-08-15

Study results available
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Summary

The intended use of the Potenza™ device is to collect clinical data for brow lifting and/or treatment of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Conditions

  • Wrinkles
  • Fine Lines
  • Crepey Skin
  • Acne Scars
  • Active Acne
  • Enlarged Pores
  • Loose Skin

Interventions

DEVICE

RF Device (Potenza™)

Test spots may be performed prior to the first treatment. Following test spots, for the treatment, the tip will be placed in contact with the skin. 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 Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2022-05-17
Completion
2022-05-17
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 NCT05254210 on ClinicalTrials.gov