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Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions

NCT05847530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-28

No results posted yet for this study

Summary

The primary objective of this pilot study is exploratory investigation evaluating the Potenza microneedle fractional radiofrequency (RF) device and may be used in combination with the Icon intense pulsed light (IPL) device.

Conditions

  • Wrinkles
  • Scars
  • Stretch Marks
  • Pigmentation
  • Skin Laxity

Interventions

DEVICE

Potenza

Subjects will receive 1-4 treatments at approximately 1 month intervals, but other intervals from 2 to 12 weeks may take place at the PI's discretion. At the discretion of the PI, additional follow-up visits may take place to observe the time course of skin reactions after treatment and/or to assess if the skin condition continues to improve beyond 3 months after treatment.

DEVICE

Icon

Subjects will receive 1-4 treatments at approximately 1 month intervals, but other intervals from 2 to 12 weeks may take place at the PI's discretion. At the discretion of the PI, additional follow-up visits may take place to observe the time course of skin reactions after treatment and/or to assess if the skin condition continues to improve beyond 3 months after treatment.

Sponsors & Collaborators

  • Cynosure, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-17
Primary Completion
2025-05-06
Completion
2025-05-06
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 NCT05847530 on ClinicalTrials.gov