CClinicalTrials.gg
CompletedNCT05847530Updated Aug 28, 2025

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

An interventional study of Potenza and Icon in Wrinkles, Scars and Stretch Marks, sponsored by Cynosure, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-28.

Sponsored by Cynosure, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Wrinkles
  • Scars
  • Stretch Marks
  • Pigmentation
  • Skin Laxity
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.
  • Willing and able to comply with all study participation requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study

Exclusion criteria

Exclusion Criteria:

  • 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
  • Psycho-neurotic condition including alcohol or drug abuse
  • Unwilling or unable to adhere to all study requirements for treatment and follow-up
  • Has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Group A

    This group is Potenza treatments only.

    Device: Potenza

  • Experimental
    Group B

    This group is Potenza and Icon treatments.

    Device: Potenza · Device: Icon

Interventions

  • DevicePotenza

    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.

  • DeviceIcon

    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.

05

What researchers measure

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.

    Time frame: 90 days post last treatment

06

Study locations

1 site
  • Scripps Clinic
    San Diego, California 92130, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05847530
Lead sponsor
Cynosure, Inc.
Responsible party
Sponsor
First posted
May 6, 2023
Start date
Aug 17, 2023
Primary completion
May 6, 2025
Completion
May 6, 2025
Last update
Aug 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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