Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions
NCT ID: NCT05847530
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2023-08-17
2025-05-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
This group is Potenza treatments only.
Potenza
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
This group is Potenza and Icon treatments.
Potenza
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.
Icon
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.
Interventions
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Potenza
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.
Icon
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Cynosure, Inc.
INDUSTRY
Responsible Party
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Locations
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Scripps Clinic
San Diego, California, United States
Countries
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Other Identifiers
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MD-PL01-2022
Identifier Type: -
Identifier Source: org_study_id
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