one clinical center between March 2019 and April 2021. The study protocol complied with the CONSORT 2010 statement for reporting a randomized controlled trial (see Supplementary Material), and the trial was conducted according to the Declaration of Helsinki and all its revisions. This study was registered to the ClinicalTrials.gov Registry (ID number: NCT03776461). All participants provided written informed consent to participate in the trial.
Male or female individuals over 21 years of age with moderate to severe wrinkles were enrolled. Women of childbearing age were required to be using a reliable method of birth control at least 3 months prior to study enrolment 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 the area of treatment, therapies or medications that may have interfered with the treatment or healing process, recent surgery in the 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 3 months, use of isotretinoin (Accutane) or other systemic retinoids within 6 months prior to treatment, and tattoo or permanent makeup in the treatment area.
Treatment Description
Test spots were performed in the intraarticular and postauricular areas 10 to 14 days before initial full-face treatments. They were carried out over a range of stacked and non-stacked passes. Skin was cleansed and dried prior to treatment. A topical anesthetic cream (5% lidocaine cream) was applied for 1 hour prior to the procedure. Additionally, refrigerated air (Cryo 6 Cold Air Chiller Device, Zimmer Medizin Systems) was applied at level 2 to 3. In selected patients who noted more severe discomfort, and with higher settings, we injected 1 cc of 1% lidocaine 1:200,000, buffered, along the supraorbital supratrochlear, infraorbital, and mental nerves.
Treatments were performed using the Venus VivaMD (Venus Concept). The study involved 3 treatments to the entire face at 3- to 5-week intervals. The distal section of the applicator on the device was cleaned and fitted with a new tip (80-pin or 160-pin) for each 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. Each treatment consisted of 1 to 5 passes over the designated area in a range (voltage: 240 V or 280 V; pulse duration: 28 ms to 30 ms). Tip selection was determined by the principal investigator. Average settings per area of the face are described in Table 1. If the test spot settings showed healing results by day 4 to 5, those settings were used for the entire face. Typically, more passes were applied in the perioral area where the skin was thicker.
The 80-pin and 160-pin applicators do not penetrate the skin but are able to deliver energy into the epidermis and superficial dermis through application of the RF energy at the surface. In general, in more severe wrinkles the 80-pin tip was used, and for milder wrinkles, the 160-pin tip was used. Participants were 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. Patients were followed at 6 and 12 weeks after their last treatment.
Outcome Measures
Performance outcomes were determined by using a Subject Satisfaction Scale (SSS) at 6 and 12 weeks post-treatment. Each patient’s SSS was evaluated using the following 5-point Likert scale: (4) very satisfied, (3) satisfied, (2) no opinion, (1) unsatisfied, and (0) very unsatisfied. Immediately after each treatment, participants were assessed for treatment pain/ discomfort using a 10 cm Visual Analog Scale (VAS)17,18 on a scale from 0 cm (no pain) to 10 cm (pain as bad as it can be). Participants were not permitted to view their previous VAS or SSS treatment scores. Additionally, following treatment, each patient’s treatment tolerability was recorded using a scale: (4) very tolerable, (3) tolerable, (2) having no opinion, (1) intolerable, and (0) very intolerable. All adverse events (AEs) were recorded up to the 12-week post-treatment visit.
Additional analysis of satisfaction was performed using a treatment evaluation questionnaire conducted at the 6-week and 12-week follow-ups. Participants were asked what level of improvement they experienced (mild, moderate, or significant), whether they would recommend this treatment to a friend (yes or no), how soon after the start of treatments they started noticing changes to their skin (after the first treatment, after the second treatment, after the third treatment, or during the followup period). Patients with wrinkles were asked what specific changes they saw in their skin (smoother skin, softer skin, firmer skin, and overall improvement in wrinkles and fine lines) and which areas of the face had the most improvement of wrinkles (forehead, perioral area, and oral area).
Statistical Analysis
Quantitative data are presented as mean, median, standard deviation (SD), standard error (SE), and/or range, as applicable, while qualitative data are presented as percentages (%). Twosided Student’s paired t test was used to test for changes from baseline to follow-up visits at 6 and 12 weeks after the last treatment. P values less than 0.05 were considered statistically significant.
Male or female individuals over 21 years of age with moderate to severe wrinkles were enrolled. Women of childbearing age were required to be using a reliable method of birth control at least 3 months prior to study enrolment 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 the area of treatment, therapies or medications that may have interfered with the treatment or healing process, recent surgery in the 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 3 months, use of isotretinoin (Accutane) or other systemic retinoids within 6 months prior to treatment, and tattoo or permanent makeup in the treatment area.
Treatment Description
Test spots were performed in the intraarticular and postauricular areas 10 to 14 days before initial full-face treatments. They were carried out over a range of stacked and non-stacked passes. Skin was cleansed and dried prior to treatment. A topical anesthetic cream (5% lidocaine cream) was applied for 1 hour prior to the procedure. Additionally, refrigerated air (Cryo 6 Cold Air Chiller Device, Zimmer Medizin Systems) was applied at level 2 to 3. In selected patients who noted more severe discomfort, and with higher settings, we injected 1 cc of 1% lidocaine 1:200,000, buffered, along the supraorbital supratrochlear, infraorbital, and mental nerves.
Treatments were performed using the Venus VivaMD (Venus Concept). The study involved 3 treatments to the entire face at 3- to 5-week intervals. The distal section of the applicator on the device was cleaned and fitted with a new tip (80-pin or 160-pin) for each 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. Each treatment consisted of 1 to 5 passes over the designated area in a range (voltage: 240 V or 280 V; pulse duration: 28 ms to 30 ms). Tip selection was determined by the principal investigator. Average settings per area of the face are described in Table 1. If the test spot settings showed healing results by day 4 to 5, those settings were used for the entire face. Typically, more passes were applied in the perioral area where the skin was thicker.
The 80-pin and 160-pin applicators do not penetrate the skin but are able to deliver energy into the epidermis and superficial dermis through application of the RF energy at the surface. In general, in more severe wrinkles the 80-pin tip was used, and for milder wrinkles, the 160-pin tip was used. Participants were 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. Patients were followed at 6 and 12 weeks after their last treatment.
Outcome Measures
Performance outcomes were determined by using a Subject Satisfaction Scale (SSS) at 6 and 12 weeks post-treatment. Each patient’s SSS was evaluated using the following 5-point Likert scale: (4) very satisfied, (3) satisfied, (2) no opinion, (1) unsatisfied, and (0) very unsatisfied. Immediately after each treatment, participants were assessed for treatment pain/ discomfort using a 10 cm Visual Analog Scale (VAS)17,18 on a scale from 0 cm (no pain) to 10 cm (pain as bad as it can be). Participants were not permitted to view their previous VAS or SSS treatment scores. Additionally, following treatment, each patient’s treatment tolerability was recorded using a scale: (4) very tolerable, (3) tolerable, (2) having no opinion, (1) intolerable, and (0) very intolerable. All adverse events (AEs) were recorded up to the 12-week post-treatment visit.
Additional analysis of satisfaction was performed using a treatment evaluation questionnaire conducted at the 6-week and 12-week follow-ups. Participants were asked what level of improvement they experienced (mild, moderate, or significant), whether they would recommend this treatment to a friend (yes or no), how soon after the start of treatments they started noticing changes to their skin (after the first treatment, after the second treatment, after the third treatment, or during the followup period). Patients with wrinkles were asked what specific changes they saw in their skin (smoother skin, softer skin, firmer skin, and overall improvement in wrinkles and fine lines) and which areas of the face had the most improvement of wrinkles (forehead, perioral area, and oral area).
Statistical Analysis
Quantitative data are presented as mean, median, standard deviation (SD), standard error (SE), and/or range, as applicable, while qualitative data are presented as percentages (%). Twosided Student’s paired t test was used to test for changes from baseline to follow-up visits at 6 and 12 weeks after the last treatment. P values less than 0.05 were considered statistically significant.
RESULTS
Patient Demographics
Twenty-five (25) participants were enrolled in the study. The mean age at consent was 60.5 years. Twenty-four (24) participants
Twenty-five (25) participants were enrolled in the study. The mean age at consent was 60.5 years. Twenty-four (24) participants
