NCT05097157

Brief Summary

Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. Up to 120 subjects will be enrolled at multiple study centers. Subjects may receive up to 5 treatments for a wide array of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
7 months until next milestone

Results Posted

Study results publicly available

June 9, 2022

Completed
Last Updated

June 9, 2022

Status Verified

May 1, 2022

Enrollment Period

1.6 years

First QC Date

October 15, 2021

Results QC Date

April 26, 2022

Last Update Submit

May 18, 2022

Conditions

WrinkleFine LinesCrepey SkinAcne ScarsAcneEnlarged PoresStretch MarksLoose Skin

Outcome Measures

Primary Outcomes (4)

  • Subject Satisfaction

    Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied.

    30 day follow up

  • Global Aesthetic Improvement Scale Assessment (GAIS) Assessment

    The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image.

    30 day follow up

  • Subject Satisfaction

    Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied.

    90 day follow up

  • Global Aesthetic Improvement Scale Assessment (GAIS) Assessment

    The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image.

    90 day follow up

Study Arms (1)

Treatment with Device

EXPERIMENTAL

Subjects received up to 5 treatments with the device, spaced 4 weeks apart.

Device: Potenza

Interventions

PotenzaDEVICE

Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.

Treatment with Device

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A healthy, non-smoking male or female between the age of 18-55 years old.
  • Fitzpatrick skin type I to VI.
  • Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
  • Understands and accepts the obligation and is logistically able to be present for all visits.
  • Is willing to comply with all requirements of the study and sign the informed consent document.

You may not qualify if:

  • Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
  • The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.
  • The subject has physical problems such as cardiovascular disorders.
  • The subject has a pacemaker.
  • The subject had previous use of gold thread skin rejuvenation.
  • The subject has skin infections.
  • The subject has any of the following conditions:
  • Diabetes
  • Epilepsy
  • Acute disease
  • Dermatitis
  • Subjects with electronic implants such as cardiac defibrillator. It may interfere with operation of electronic implants or damage the implants, causing risks.
  • The subject 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Center for Dermatology and Laser Surgery

Sacramento, California, 95819, United States

Location

Maryland Dermatology Laser, Skin, & Vein Institute, LLC.

Hunt Valley, Maryland, 21030, United States

Location

Cynosure

Westford, Massachusetts, 01886, United States

Location

McDaniel Institute of Anti-Aging Research

Virginia Beach, Virginia, 23462, United States

Location

Related Publications (1)

  • Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.

    PMID: 31896400RESULT

MeSH Terms

Conditions

Acne VulgarisStriae DistensaeCutis Laxa

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue Diseases

Results Point of Contact

Title
Jamie Trimper
Organization
Cynosure
jamie.trimper@cynosure.com
(978) 256-4200

Study Officials

  • Jennifer Civiok

    Cynosure, Inc.

    STUDY DIRECTOR

  • Sean Doherty

    Cynosure, Inc.

    PRINCIPAL INVESTIGATOR

  • Robert Weiss

    Maryland Dermatology Laser, Skin, & Vein Institute, LLC

    PRINCIPAL INVESTIGATOR

  • Emil Tanghetti

    Center for Dermatology and Laser Surgery

    PRINCIPAL INVESTIGATOR

  • David McDaniel

    McDaniel Institute of Anti-Aging Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2021

First Posted

October 28, 2021

Study Start

September 3, 2019

Primary Completion

April 12, 2021

Study Completion

June 21, 2021

Last Updated

June 9, 2022

Results First Posted

June 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(4)