Clinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction of Acne Scarring

NCT04827680 | Completed Results FDA Device

• 1 other identifier: VI0121
• Study Type: interventional
• Target: 20
• 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 the progress of 20 subjects requesting treatment of 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 - Mixed Atrophic and Hypertrophic

Keywords

acne scarring; acne scar; fractional radiofrequency; fractional RF; FRF

Outcome Measures

Primary Outcomes (1)

• Subject Satisfaction

  Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale at 12 weeks post-treatment. The Subject Satisfaction Scale is a five-grade subjective test. Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.

  12 Weeks Post-Final Treatment

Secondary Outcomes (2)

• Treatment Pain

  Average of all treatments

• Subject Scale - 5 Point Scale for Treatment Tolerability

  Average of all treatments

Study Arms (1)

All subjects

EXPERIMENTAL

The Venus Viva™ fractional RF device 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.

Device: Venus Viva MD

Interventions

Venus Viva MD DEVICE

The Venus Viva™ MD fractional RF device 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.

All subjects

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 over 21 years of age who are seeking treatment and reduction of their 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 systemic retinoids within six months or topical retinoids within three months prior to treatment; or as per physician's discretion.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Sadick Research Group

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Venus Concept

mgronski@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: NA
• Masking: NONE
• Masking Details: Blinded evaluation of photographs taken at baseline and at 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: March 29, 2021
• First Posted: April 1, 2021
• Study Start: May 1, 2021
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: October 4, 2023
• Results First Posted: October 4, 2023

Record last verified: 2023-09

Locations

US (1)