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

NCT05847530 | Completed FDA Device

• 1 other identifier: MD-PL01-2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Grading of Skin Aging and Photodamage

  At the 90 day follow up, subjects will be graded on a scale of 0-4 (0 being none and 4 being severe) for the presence of skin aging and photodamage. The # of subjects with improvement will be reported.

  90 days post last treatment

Study Arms (2)

Group A

EXPERIMENTAL

This group is Potenza treatments only.

Device: Potenza

Group B

EXPERIMENTAL

This group is Potenza and Icon treatments.

Device: Potenza; Device: Icon

Interventions

Potenza DEVICE

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.

Group A; Group B

Icon DEVICE

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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female 18 years of age or older.
• Presence of unwanted dermatologic condition suitable for treatment such as facial and/or neck wrinkles, skin laxity of face, neck or body, scars, acne scars or striae, or Vascular and/or pigment dyschromia
• Ability to read, understand, and sign the Informed Consent Form
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated and/or weight loss through the follow-up period.

You may not qualify if:

• Is pregnant or of childbearing potential and not using (or willing to use) medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
• Presence of an active systemic or local skin disease or condition that may affect wound healing or interfere with participation.
• History of keloids or poor wound healing
• Taking medication which is known to increase sensitivity to sunlight
• Has a seizure disorders triggered by light
• Cancer, malignant disease, skin pathology, condition or allergic reactions that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments
• History of collagen, vascular or immunosuppressive or deficiency disorders
• History of coagulative disorder or use of anticoagulant drugs within 2 weeks of study treatment
• Use of steroids within 2 weeks of study treatments
• Use of Accutane (isotretinoin) in the past 12 months
• Previous surgical or cosmetic procedure to the target area in the last 6 to 12 months that could interfere with the treatment procedure and affect treatment outcome
• Has an implanted pacemaker or defibrillator, metal pins or prosthetic joints
• Allergic reaction to gold metal
• Receiving or have received gold therapy
• Photo-sensitive skin

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

Scripps Clinic

San Diego, California, 92130, United States

Location

MeSH Terms

Conditions

Cicatrix; Striae Distensae; Cutis Laxa

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization is not requires, as the group to which a subject is assigned to will be at the discretion of the investigator.

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: August 17, 2023
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)