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

Sponsor

Cynosure, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05847530

Collaborator

(none)

Enrollment

Location

Arms

18.1

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Wrinkles Scars Stretch Marks Pigmentation Skin Laxity	Device: Potenza Device: Icon	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomization is not requires, as the group to which a subject is assigned to will be at the discretion of the investigator.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)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A This group is Potenza treatments only.	Device: 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.
Experimental: Group B This group is Potenza and Icon treatments.	Device: 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. Device: 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.

Arm

Intervention/Treatment

Experimental: Group A

This group is Potenza treatments only.

Device: 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.

Experimental: Group B

This group is Potenza and Icon treatments.

Device: Potenza

Device: Icon

Outcome Measures

Primary Outcome Measures

Grading of Skin Aging and Photodamage [90 days post last treatment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Clinic	San Diego	California	United States	92130

Sponsors and Collaborators

Cynosure, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cynosure, Inc.

ClinicalTrials.gov Identifier:

NCT05847530

Other Study ID Numbers:

MD-PL01-2022

First Posted:

May 6, 2023

Last Update Posted:

May 10, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Skin Diseases

Striae Distensae

Study Results

No Results Posted as of May 10, 2023