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Completed

NCT Number: NCT05097157

Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions

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.

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Key information

Conditions

Wrinkle Acne Acne Scars Acne Vulgaris Acneiform Eruptions Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Crepey Skin Cutis Laxa Enlarged Pores Fine Lines Genetic Diseases, Inborn Loose Skin Pathological Conditions, Signs and Symptoms Sebaceous Gland Diseases Signs and Symptoms Skin Diseases Skin Diseases, Genetic Skin Manifestations Skin and Connective Tissue Diseases Stretch Marks Striae Distensae

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Dermatology and Laser Surgery, Sacramento, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Potenza

Device

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.

Primary outcomes

  1. Subject Satisfaction

    Time frame: 30 day follow up

    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.

  2. Global Aesthetic Improvement Scale Assessment (GAIS) Assessment

    Time frame: 30 day follow up

    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.

  3. Subject Satisfaction

    Time frame: 90 day follow up

    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.

  4. Global Aesthetic Improvement Scale Assessment (GAIS) Assessment

    Time frame: 90 day follow up

    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.

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Official study title

Feasibility Study To Assess A Radiofrequency Microneedling Device For Electrocoagulation And Hemostasis Of Soft Tissues For Dermatologic Conditions

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2021
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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