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

Sponsor

Venus Concept (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04827680

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Scars - Mixed Atrophic and Hypertrophic	Device: Venus Viva	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

Blinded evaluation of photographs taken at baseline and at 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

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Venus Viva 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. 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.	Device: Venus Viva 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. 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.

Arm

Intervention/Treatment

Experimental: Venus Viva

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. 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.

Device: Venus Viva

Outcome Measures

Primary Outcome Measures

Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Post-Final Treatment [12 Weeks Post-Final Treatment]
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).

Secondary Outcome Measures

Subject Satisfaction [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. The Subject Satisfaction Scale is a five-grade subjective test. Participant were asked their satisfaction level post treatment. Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.
Subject Scale - Visual Analog Scale for Pain [12 Weeks Post-Final Treatment]
Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS). The Visual Analog Scale is a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be). Possible responses were of 0 to 0.4 cm can be considered (no pain); 0.5 to 4.4 cm (mild pain), 4.5 to 7.4 cm (moderate pain), and 7.5 to 10 cm (severe pain).
Incidence of Treatment-Related Adverse Events [12 Weeks Post-Final Treatment]
Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment.
Subject Scale - 5 Point Scale for Treatment Tolerability [12 Weeks Post-Final Treatment]
Subject's assessment of treatment tolerability as measured by a 5 point scale. Participant were asked their tolerability level post treatment. Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofencontaining agents) one week before and after each treatment session.
Any surgical procedure in the treatment area within the last six months or before complete healing.
Treating over tattoo or permanent makeup.
Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.