Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Cond… (NCT05847530) | Clinical Trial Compass
CompletedNot Applicable
Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions
United States20 participantsStarted 2023-08-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 deficie…