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

Launched by CYNOSURE, INC. · Apr 27, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a new device called the Potenza microneedle fractional radiofrequency system to treat common skin concerns such as wrinkles, scars, stretch marks, uneven pigmentation, and loose skin. The study aims to see how effective this treatment is, and it might also involve using another device called the Icon intense pulsed light (IPL) to enhance results. The trial is currently looking for participants aged 18 and older who have these skin issues and are healthy enough to join.

To participate, individuals must be willing to follow the study rules, which include not having any other skin treatments in the areas being treated during the study period. However, certain people may not qualify, such as those who are pregnant, have specific skin conditions, or have recently undergone other cosmetic procedures. Participants can expect several visits to the clinic for treatment and follow-up, and they will be closely monitored throughout the study to ensure their safety and gather valuable information about the treatment's effectiveness.

Gender

ALL

Eligibility criteria

• 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:
• • 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.