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Clinical Evaluation of Fractional Radiofrequency for the Treatment of Acne Scarring

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ClinicalTrials.gov Identifier: NCT03767153
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Venus Concept

Brief Summary:
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of acne scarring. The study will evaluate 50 treatment sites in subjects requesting treatment of their acne scarring. The study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment.

Condition or disease Intervention/treatment Phase
Acne Scars Device: Venus Viva Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Blinded assessment of photographs taken at baseline and 6, 12 weeks post final treatment by independent evaluators.
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Acne Scarring
Estimated Study Start Date : December 5, 2018
Estimated Primary Completion Date : October 5, 2019
Estimated Study Completion Date : December 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars


Intervention Details:
  • Device: Venus Viva

    The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.

    Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.



Primary Outcome Measures :
  1. Acne Scar Improvement [ Time Frame: 6 and 12 Weeks Post-Final Treatment ]
    Change in acne scarring at 6 weeks and 12 weeks post-treatment compared to baseline as assessed by blinded evaluators by photographic assessment utilizing a 7 point Global Aesthetic Improvement Scale


Secondary Outcome Measures :
  1. Subject Satisfaction [ Time Frame: 6 and 12 Weeks Post- Final Treatment ]
    Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale at 6 weeks and 12 weeks post-treatment.

  2. Subject Scale - Visual Analog Scale for Pain [ Time Frame: 6 and 12 Weeks Post-Final Treatment ]
    Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS)

  3. Incidence of Treatment-Related Adverse Events [Safety] [ Time Frame: Up to 12 Weeks Post-Final Treatment ]
    Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment.

  4. Subject Scale - 5 Point Scale for Treatment Tolerability [ Time Frame: 6 and 12 Weeks Post-Final Treatment ]
    Subject's assessment of treatment tolerability as measured by a 5 point scale



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy, male or female subjects 22 years of age or over who are seeking treatment and reduction of their facial acne scarring.
  2. Able to read, understand and voluntarily provide written Informed Consent.
  3. Able and willing to comply with the treatment/follow-up schedule and requirements.
  4. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.

Exclusion Criteria:

  1. Implantable defibrillators, cardiac pacemakers, and other metal implants
  2. Subjects with any implantable metal device in the treatment area
  3. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
  4. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
  5. Current or history of any kind of cancer, or pre-malignant moles.
  6. Severe concurrent conditions, such as cardiac disorders.
  7. Pregnancy or intending to become pregnant during the study and nursing.
  8. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
  9. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only after a prophylactic regime has been followed for 2 weeks or longer prior to enrollment, or according to Investigator's discretion .
  10. Poorly controlled endocrine disorders, such as diabetes.
  11. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
  12. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
  13. History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin).
  14. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
  15. Use of isotretinoin (Accutane®) or other retinoids within six months prior to treatment or as per physician's discretion.
  16. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing agents) one week before and after each treatment session.
  17. Any surgical procedure in the treatment area within the last six months or before complete healing.
  18. Treating over tattoo or permanent makeup.
  19. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
  20. As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767153


Contacts
Contact: Louie Cabigao, CCRP 9057492610 lcabigao@venusconcept.com
Contact: Andrea Biro, M.Sc, CCRP 289-552-7111 abiro@venusconcept.com

Locations
United States, Florida
Leavitt Medical Associates of Florida d/b/a Ameriderm Research Recruiting
Port Orange, Florida, United States, 32127
Contact: Sandra Warrington    386-523-0768    Sandra.Warrington@Leavittmgt.com   
Principal Investigator: Stephen Eubanks, MD         
Sponsors and Collaborators
Venus Concept
Investigators
Study Director: Paul Cardarelli Venus Concept

Responsible Party: Venus Concept
ClinicalTrials.gov Identifier: NCT03767153     History of Changes
Other Study ID Numbers: VI1018
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Venus Concept:
acne scarring
acne scar
fractional radiofrequency
fractional RF

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes