COMPLETED

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

Conditions

Wrinkles Scars Stretch Marks Pigmentation Skin Laxity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-08-17

Study Completion:2025-05-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05847530

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Locations (Sites)

Scripps Clinic

San Diego, California, 92130

United States

Collaborators and Investigators

Sponsor: Cynosure, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-17

Study Completion Date2025-05-06

Study Record Updates

Study Start Date2023-08-17

Study Completion Date2025-05-06

Terms related to this study

Additional Relevant MeSH Terms

Wrinkles
Scars
Stretch Marks
Pigmentation
Skin Laxity