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

Last updated: July 25, 2024
Sponsor: Cynosure, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Skin Aging

Skin Wounds

Stretch Marks

Treatment

Potenza

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Clinical Study ID

NCT05847530
MD-PL01-2022
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy male or female 18 years of age or older.

  • Presence of unwanted dermatologic condition suitable for treatment such as facialand/or neck wrinkles, skin laxity of face, neck or body, scars, acne scars orstriae, 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 theareas to be treated and/or weight loss through the follow-up period.

  • Willing and able to comply with all study participation requirements includingreturning for follow-up visits and abstaining from exclusionary procedures for theduration of the study

Exclusion

Exclusion Criteria:

  • Is pregnant or of childbearing potential and not using (or willing to use) medicallyeffective birth control, or has been pregnant in the last 3 months, currently breastfeeding or planning a pregnancy during the study.

  • Presence of an active systemic or local skin disease or condition that may affectwound 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 thatcould interfere with evaluation or with the use of typical ancillary medicaltreatments 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 ofstudy 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 12months that could interfere with the treatment procedure and affect treatmentoutcome

  • 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 putthe subject at significant risk, may confound study results or may interferesignificantly with the subject's participation.

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Potenza
Phase:
Study Start date:
September 01, 2024
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • Scripps Clinic

    San Diego, California 92130
    United States

    Active - Recruiting

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