Clinical Evaluation of Fractional Radiofrequency for the Treatment of Acne Scarring

NCT03767153 | Completed Results FDA Device

• 1 other identifier: VI1018
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Scars

Keywords

acne scarring; acne scar; fractional radiofrequency; fractional RF

Outcome Measures

Primary Outcomes (1)

• Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks.

  Evaluate the efficacy of overall facial acne scar improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a seven-grade subjective test. Three independent evaluators evaluated before and after photographs and graded them for change. Possible responses were (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3).

  12 Weeks Post-Final Treatment

Secondary Outcomes (4)

• Subject Satisfaction

  6 Weeks and 12 Weeks Post- Final Treatment

• Subject Scale - Visual Analog Scale for Pain

  12 Weeks Post-Final Treatment

• Number of Participants With Treatment-Related Adverse Events [Safety]

  Up to 12 Weeks Post-Final Treatment

• Subject Scale - 5 Point Scale for Treatment Tolerability

  12 Weeks Post-Final Treatment

Study Arms (2)

80 pin applicator

EXPERIMENTAL

Device: Venus Viva

160 pin applicator

ACTIVE COMPARATOR

Device: Venus Viva

Interventions

Venus Viva DEVICE

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.

160 pin applicator; 80 pin applicator

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, male or female subjects 22 years of age or over who are seeking treatment and reduction of their facial acne scarring.
• Able to read, understand and voluntarily provide written Informed Consent.
• Able and willing to comply with the treatment/follow-up schedule and requirements.
• 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.

You may not qualify if:

• Implantable defibrillators, cardiac pacemakers, and other metal implants
• Subjects with any implantable metal device in the treatment area
• Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
• Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
• Current or history of any kind of cancer, or pre-malignant moles.
• Severe concurrent conditions, such as cardiac disorders.
• Pregnancy or intending to become pregnant during the study and nursing.
• Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
• 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 .
• Poorly controlled endocrine disorders, such as diabetes.
• Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
• History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin).
• Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
• Use of isotretinoin (Accutane®) or other retinoids within six months prior to treatment or as per physician's discretion.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Leavitt Medical Associates of Florida d/b/a Ameriderm Research

Port Orange, Florida, 32127, United States

Location

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Venus Concept

rmays@venusconcept.com

888-907-0115

Study Officials

• Matthew Gronski

  Venus Concept

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessment of photographs taken at baseline and 6, 12 weeks post final treatment by independent evaluators.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 6, 2018
• Study Start: November 5, 2018
• Primary Completion: November 22, 2019
• Study Completion: December 22, 2019
• Last Updated: March 23, 2021
• Results First Posted: March 23, 2021

Record last verified: 2021-02

Locations

US (1)