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

Primary Purpose

Wrinkles, Scars, Stretch Marks

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Potenza
Icon
Sponsored by
Cynosure, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrinkles

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scripps ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

This group is Potenza treatments only.

This group is Potenza and Icon treatments.

Outcomes

Primary Outcome Measures

Grading of Skin Aging and Photodamage
At the 90 day follow up, subjects will be graded on a scale of 0-4 (0 being none and 4 being severe) for the presence of skin aging and photodamage. The # of subjects with improvement will be reported.

Secondary Outcome Measures

Full Information

First Posted
April 27, 2023
Last Updated
October 17, 2023
Sponsor
Cynosure, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05847530
Brief Title
Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions
Official Title
Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cynosure, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrinkles, Scars, Stretch Marks, Pigmentation, Skin Laxity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization is not requires, as the group to which a subject is assigned to will be at the discretion of the investigator.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
This group is Potenza treatments only.
Arm Title
Group B
Arm Type
Experimental
Arm Description
This group is Potenza and Icon treatments.
Intervention Type
Device
Intervention Name(s)
Potenza
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Icon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Grading of Skin Aging and Photodamage
Description
At the 90 day follow up, subjects will be graded on a scale of 0-4 (0 being none and 4 being severe) for the presence of skin aging and photodamage. The # of subjects with improvement will be reported.
Time Frame
90 days post last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Trimper
Phone
(978) 256-4200
Email
jamie.trimper@cynosure.com
Facility Information:
Facility Name
Scripps Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Ross

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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