the targeted predetermined fractional impacted tissue zones, maintains skin integrity and serves to promote and accelerate wound healing. Fractional radiofrequency was developed with the same conceptual framework as fractional lasers, which is to provide focal, high-energy treatment zones within intact skin for the purpose of reduced downtime and risk. Furthermore, FRF is not selectively absorbed by chromophores, so it is considered safe to use in darker skin.1
Fractional radiofrequency technology has been shown to improve skin laxity, and to treat various skin conditions related to aging and alternate collagen structures resulting in appearance alterations such as rhytids. The objective of this study was, therefore, to evaluate the safety and efficacy of using an FRF device with an 80-pin tip (up to 124 mJ per pin) to reduce moderate to severe facial rhytids and elastosis.
Fractional radiofrequency technology has been shown to improve skin laxity, and to treat various skin conditions related to aging and alternate collagen structures resulting in appearance alterations such as rhytids. The objective of this study was, therefore, to evaluate the safety and efficacy of using an FRF device with an 80-pin tip (up to 124 mJ per pin) to reduce moderate to severe facial rhytids and elastosis.
MATERIALS AND METHODS
Participants
This was a prospective, evaluator-blind, study conducted at one clinical center between August 2019 and January 2020. The study protocol complied with the CONSORT 2010 statement for reporting randomized controlled trial, and the trial was conducted according to the Declaration of Helsinki and all its revisions. It was approved by the Western Institutional Review Board (IRB approval number: 1262764). This study was registered to the ClinicalTrials.gov Registry (ID number: NCT04057768). All subjects provided written informed consent to participate in the trial.
Male or female subjects over 21 years of age with moderate to severe rhytids who were seeking treatment and reduction of their wrinkles were enrolled. Women of child-bearing age were required to be using a reliable method of birth control at least three months prior to study enrollment and for the duration of the study and have a negative urine pregnancy test at baseline.
The exclusion criteria were: the presence of pacemaker or defibrillator, metal implants, pregnancy, any past or current significant systemic illness, illness localized in area of treatment, therapies or medication that may have interfered with the treatment or healing process, recent surgery in treatment area, acute or chronic infection in the area, any active condition in the treatment area, any history of skin disorders, facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, use of isotretinoin (Accutane®) or other systemic retinoids within six months prior to treatment, and tattoo or permanent makeup in the treatment area.
Description of Treatment
Skin in the treatment area was cleansed and dried prior to treatment. Treatments were performed using the Venus VivaMDTM (Venus Concept, Toronto, Canada). The study involved three treatments on both sides of the face with 3 to 5-week intervals between each treatment. Subjects were followed at 6- and 12- weeks after their last treatment. To begin the treatment, subjects lay in a supine position. The distal section of the applicator on the device was cleaned and fitted with a new tip (80 pins) per patient. The applicator was then held perpendicular to the skin, and with the distal part of the tip in close contact with the skin for the application of the treatment. Treatment consisted of two passes over the designated area in a range of energies (voltage: 240 or 260, pulse duration: 15 or 30 milliseconds). Subjects were advised to avoid possible thermal or mechanical damage after the treatment. Subjects were also instructed to use a high factor of sunscreen (SPF ≥ 30) to protect the treated area from direct sunlight for the entire period of the study.
Outcome Measures
All evaluations were conducted with blinded evaluation of clinical photography as well as investigator and patient assessments. Clinical photographs were taken at each treatment and follow-up visit. Photographs were taken with standardized photography equipment including stool height and anatomical alignment, illumination, and background throughout the study.
The primary outcome measures was the Fitzpatrick Wrinkle and Elastosis Scale (FWES): (1–3) mild, meaning fine texture changes with subtly accentuated skin lines, (3–6) moderate, meaning distinct papular elastosis (individual papules with yellow translucency under direct lighting) and dyschromia, (6–9) severe, meaning multipapular and confluent elastosis (thickened, yellow and pallid) approaching or consistent with cutis rhomboidalis.17 The FWES was used to assess the wrinkles on the face overall, the upper lip, perioral area, and crow's feet. The other primary outcome measure was improvement in acne scarring at 6- and 12-weeks post-treatment, compared to baseline, as assessed by blinded evaluators by photographic assessment utilizing the Global Aesthetic Improvement Scale (GAIS): (3) very much improved, (2) much improved, (1) improved, (0) no change, and (-1) worse.
Secondary performance outcomes were the subjects' assessments of satisfaction with the treatment using a Subject Satisfaction Scale at 6- and 12-weeks post-treatment. Subject satisfaction was evaluated with the following 5-point Likert scale: (4) very satisfied, (3) satisfied, (2) no opinion, (1) unsatisfied, (0) very unsatisfied. Immediately after each treatment, subject discomfort was assessed using a 11-point Wong Baker FACES Pain Scale (WBFS) on a scale from 0 (no pain) and 10 (worst pain imaginable).18 Subjects were not permitted to view their previous WBFS treatment scores. All adverse events (AEs) were recorded up to the 12-week post-treatment visit.
Statistical Analysis
Quantitative data are presented as mean, median, standard
This was a prospective, evaluator-blind, study conducted at one clinical center between August 2019 and January 2020. The study protocol complied with the CONSORT 2010 statement for reporting randomized controlled trial, and the trial was conducted according to the Declaration of Helsinki and all its revisions. It was approved by the Western Institutional Review Board (IRB approval number: 1262764). This study was registered to the ClinicalTrials.gov Registry (ID number: NCT04057768). All subjects provided written informed consent to participate in the trial.
Male or female subjects over 21 years of age with moderate to severe rhytids who were seeking treatment and reduction of their wrinkles were enrolled. Women of child-bearing age were required to be using a reliable method of birth control at least three months prior to study enrollment and for the duration of the study and have a negative urine pregnancy test at baseline.
The exclusion criteria were: the presence of pacemaker or defibrillator, metal implants, pregnancy, any past or current significant systemic illness, illness localized in area of treatment, therapies or medication that may have interfered with the treatment or healing process, recent surgery in treatment area, acute or chronic infection in the area, any active condition in the treatment area, any history of skin disorders, facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, use of isotretinoin (Accutane®) or other systemic retinoids within six months prior to treatment, and tattoo or permanent makeup in the treatment area.
Description of Treatment
Skin in the treatment area was cleansed and dried prior to treatment. Treatments were performed using the Venus VivaMDTM (Venus Concept, Toronto, Canada). The study involved three treatments on both sides of the face with 3 to 5-week intervals between each treatment. Subjects were followed at 6- and 12- weeks after their last treatment. To begin the treatment, subjects lay in a supine position. The distal section of the applicator on the device was cleaned and fitted with a new tip (80 pins) per patient. The applicator was then held perpendicular to the skin, and with the distal part of the tip in close contact with the skin for the application of the treatment. Treatment consisted of two passes over the designated area in a range of energies (voltage: 240 or 260, pulse duration: 15 or 30 milliseconds). Subjects were advised to avoid possible thermal or mechanical damage after the treatment. Subjects were also instructed to use a high factor of sunscreen (SPF ≥ 30) to protect the treated area from direct sunlight for the entire period of the study.
Outcome Measures
All evaluations were conducted with blinded evaluation of clinical photography as well as investigator and patient assessments. Clinical photographs were taken at each treatment and follow-up visit. Photographs were taken with standardized photography equipment including stool height and anatomical alignment, illumination, and background throughout the study.
The primary outcome measures was the Fitzpatrick Wrinkle and Elastosis Scale (FWES): (1–3) mild, meaning fine texture changes with subtly accentuated skin lines, (3–6) moderate, meaning distinct papular elastosis (individual papules with yellow translucency under direct lighting) and dyschromia, (6–9) severe, meaning multipapular and confluent elastosis (thickened, yellow and pallid) approaching or consistent with cutis rhomboidalis.17 The FWES was used to assess the wrinkles on the face overall, the upper lip, perioral area, and crow's feet. The other primary outcome measure was improvement in acne scarring at 6- and 12-weeks post-treatment, compared to baseline, as assessed by blinded evaluators by photographic assessment utilizing the Global Aesthetic Improvement Scale (GAIS): (3) very much improved, (2) much improved, (1) improved, (0) no change, and (-1) worse.
Secondary performance outcomes were the subjects' assessments of satisfaction with the treatment using a Subject Satisfaction Scale at 6- and 12-weeks post-treatment. Subject satisfaction was evaluated with the following 5-point Likert scale: (4) very satisfied, (3) satisfied, (2) no opinion, (1) unsatisfied, (0) very unsatisfied. Immediately after each treatment, subject discomfort was assessed using a 11-point Wong Baker FACES Pain Scale (WBFS) on a scale from 0 (no pain) and 10 (worst pain imaginable).18 Subjects were not permitted to view their previous WBFS treatment scores. All adverse events (AEs) were recorded up to the 12-week post-treatment visit.
Statistical Analysis
Quantitative data are presented as mean, median, standard
