Comparing safety and efficacy of acoustic subcision at two different rapid acoustic pulse rates to improve the appearance of cellulite.

BACKGROUND: A recent study showed the safety and efficacy of a noninvasive acoustic subcision device to improve the appearance of cellulite via delivery of rapid acoustic pulses in a single treatment visit. OBJECTIVE: To evaluate and compare the safety and efficacy of a single rapid acoustic pulse treatment visit using an equivalent number of rapid acoustic pulses at a pulse rate of 100 or 50 Hz. METHODS: This single-center, prospective study enrolled 15 adult women with moderate to severe cellulite according to the Cellulite Dimple-At Rest Scale. Each participant would receive nominally 72,000 rapid acoustic pulses at a pulse rate of 50 Hz on the left buttock and thigh, and nominally 72,000 rapid acoustic pulses at a pulse rate of 100 Hz on the right buttock and thigh within one treatment visit. Efficacy was assessed by the ability of blinded, independent reviewers to correctly distinguish the pre- and post-treatment photos, participant satisfaction, and the change in Cellulite Dimple-At Rest scores for each treatment side. Safety was monitored throughout the conduct of the study. RESULTS: For both 100 and 50 Hz pulse rate treated areas, the majority (two out of three) of blinded reviewers correctly identified 100% of the pre/post-treatment photos. For both the 100 and 50 Hz treated areas, 80% of participants agreed/strongly agreed that their cellulite appeared improved at the 12-week follow-up visit. Significant improvements in Cellulite Dimple-At Rest scores were seen for both the 100 and 50 Hz treated areas. All participants thought both the 100 and 50 Hz pulse rate treatments were tolerable, and the pain (mean score ± SD; 2.2 ± 1.2) associated with each was identical. No unexpected or serious adverse events occurred. CONCLUSION: Acoustic subcision delivered via rapid acoustic pulses at 100 Hz, compared to 50 Hz, provides equivalent improvement in the appearance of cellulite while maintaining a similar safety and efficacy profile. For both pulse rates, treatment pain was minimal, and participant satisfaction was high.

A Prospective, Multicenter, Evaluator-Blind, Randomized, Controlled Study of Belotero Balance (+), a Hyaluronic-Acid Filler with Lidocaine, for Correction of Infraorbital Hollowing in Adults.

BACKGROUND: The infraorbital hollow (IOH) is a concavity that interrupts the smooth transition between the lower eyelid and the cheek, resulting in a fatigued and aged appearance. Injectable fillers may be used to correct volume deficit in the under-eye area, restoring a more youthful appearance. OBJECTIVES: To demonstrate the effectiveness and safety of a Cohesive Polydensified Matrix® (CPM) hyaluronic acid (HA) filler with lidocaine (Belotero Balance® (+)) for correcting volume deficit in the IOH. METHODS: Eligible patients with a moderate or severe rating on the Merz Infraorbital Hollow Assessment Scale (MIHAS) were randomized 2:1 to treatment or control. Controls remained untreated until Week 8 and were then treated. Touch-up injections were allowed; retreatment was offered only in the treatment group. Effectiveness was evaluated by the MIHAS. Adverse events were recorded over a 76-week period. RESULTS: The estimated average response rate (≥ 1 point MIHAS improvement) was 80.6% [95% confidence interval (CI): 71.4%, 87.4%] in treated patients and 1.9% [95% CI: 0.3%, 10.2%] in controls at Week 8. The difference in estimated response rates was 78.7% [95% CI: 66.3%, 85.6%], demonstrating a statistically significant, superior response rate in treated patients compared to untreated controls. A total of 88/97 (90.7%) patients who responded to treatment at Week 8 retained improvement 48 weeks after treatment. Use of Belotero Balance (+) in the IOH had a favorable safety profile, with no unexpected adverse events reported. CONCLUSIONS: Belotero Balance (+) is a safe and effective treatment for correcting volume deficit in the IOH.

Understanding Platysma Muscle Contraction Pattern and Its Relationship to Platysmal Banding: A Real-Time Ultrasound Study.

BACKGROUND: Addressing neck contouring with surgical and nonsurgical aesthetic procedures includes understanding the origin of platysmal banding. A theory was postulated to explain this phenomenon by isometric vs isotonic muscular contraction patterns. However, no scientific proof had been provided to date for its correctness. OBJECTIVES: The aim of this study was to confirm the correctness of the platysmal banding theory based on isometric vs isotonic muscular contractions. METHODS: Eighty platysma muscles from 40 volunteers (15 males and 25 females) were investigated (mean age 41.8; SD 15.2 years; mean BMI of 22.2; SD 2.3 kg/m2). Real-time ultrasound imaging was utilized to measure the increase in local muscle thickness inside and outside of a platysmal band as well as platysma mobility. RESULTS: Within a platysmal band, the local thickness of the muscle increases during muscular contractions by 0.33 mm (37.9%; P < .001). Outside of a platysmal band the thickness of the platysma muscle decreased by 0.13 mm (20.3%; P < .001). It was identified that within a platysmal band no gliding was detectable, whereas outside of a band an average muscle gliding of 2.76 mm was observed. CONCLUSIONS: The results confirm the correctness of the isometric vs isotonic platysma muscle contraction pattern theory: isotonic muscle contraction (gliding without increase in tension and therefore in muscle thickness) vs isometric muscle contraction (no gliding but increase in tension and therefore in muscle thickness). These 2 types of contraction patterns occur within the platysma simultaneously and are an indicator for zones of adhesion in the neck to guide surgical and nonsurgical aesthetic procedures.

Identifying Levels of Competency in Aesthetic Medicine: A Questionnaire-Based Study.

BACKGROUND: In 2022, the US experienced a significant increase in demand for minimally invasive aesthetic procedures, underscoring its rising acceptance amidst an unregulated educational environment for practitioners. The absence of standardized educational pathways and quality control in aesthetic medicine, primarily provided by non-academic institutions, highlights a critical need for establishing educational standards to ensure practitioner competence and patient safety. OBJECTIVES: To identify levels of competency for the aesthetic practitioner and for necessary achievement milestones during the educational path from novice to expert injector. METHODS: A total of n = 386 international study participants responded to an online questionnaire regarding their experience in aesthetic medicine practice. The questionnaire comprised 58 questions focusing on professional data, the perceived difficulty of injection and risk for the occurrence of adverse events for specific facial regions in soft tissue filler and toxin injections. RESULTS: Regardless of medical specialty and experience level, an average of 3.85 (1.8) years, 786.4 (2,628) filler injections, and 549.9 (1,543) toxin injections was estimated to progress from novice to advanced injector, while an average of 6.10 (3.7) years, 1,842.2 (4,793) filler injections, and 1,308.5 (3,363) injections was estimated to advance from advanced to expert injector. The nose and the perioral region have been ranked as the facial regions most difficult to achieve a perfect aesthetic outcome and with the greatest risk for the occurrence of adverse events for filler and toxin injections, respectively. CONCLUSIONS: This study establishes an educational framework in aesthetic medicine by defining the progression from novice to competent and expert injector levels, suggesting 4 years of practice and over 790 filler and 550 neuromodulator injections for competence, and at least 6 years with 1,840 filler and 1,310 neuromodulator injections for expertise. It also identifies critical facial regions for targeted treatments by different expertise levels.

Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines.

BACKGROUND: RelabotulinumtoxinA (RelaBoNT-A, Galderma, Uppsala, Sweden) is an innovative, ready-to-use liquid botulinum toxin A, produced using PEARLTM manufacturing technology that yields a potent, complex-free formulation. OBJECTIVES: The READY-1 study examined efficacy and safety outcomes following a single RelaBoNT-A treatment for glabellar line correction. METHODS: Adults with moderate-to-severe glabellar lines received RelaBoNT-A (50 U) or placebo in a 3:1 randomized, 6-month, Phase 3, multicenter, double-blind study. Primary endpoints (examined at Month 1, maximum frown) comprised the composite ≥2-grade response, defined as ≥2-grades' improvement from baseline on concurrent investigator (GL-ILA) and subject (GL-SLA) severity scales (US endpoint), and the investigator-reported responder rate for subjects scored as 0 (none) or 1 (mild) (GL-ILA scale only; EU endpoint). Subject satisfaction and treatment-emergent adverse events (TEAEs) were reported. RESULTS: Overall, 297 adults were randomized and treated. Month 1 composite ≥2-grade responder rate was 82.9% (RelaBoNT-A, N=199) versus 0% (placebo, N=67; p<0.001). Month 1 investigator-reported none-or-mild responder rate was 96.3% (RelaBoNT-A) versus 4.5% (placebo; p<0.001). GL-ILA scores (none-or-mild; ≥1-grade improvement) remained higher with RelaBoNT-A (23.6%; 58.1%) versus placebo (1.5%; 10.4%) through Month 6 (p<0.001). In the Kaplan-Meier analysis, 75% still showed GL-ILA and GL-SLA improvements from baseline at 169 days (end-of-study). Subjects reported onset of effect from Day 1 (39%) and satisfaction with natural-looking results (96.8%; Month 1). RelaBoNT-A-related TEAEs were low (3.6%) and typically mild. CONCLUSIONS: A single RelaBoNT-A treatment was effective and demonstrated a favorable safety profile. RelaBoNT-A provided significant improvements in glabellar line severity, high satisfaction, rapid onset, and enduring effectiveness throughout the 6-month study period.

A Multicenter, Randomized, Evaluator-Blinded Study to Examine the Safety and Effectiveness of Hyaluronic Acid Filler in the Correction of Infraorbital Hollows.

BACKGROUND: Hyaluronic acid injections are increasingly used for correction of infraorbital hollows (IOHs). OBJECTIVES: Examination of effectiveness (IOH correction) and safety of Restylane® EyelightTM hyaluronic acid (HAEYE, Galderma, Uppsala, Sweden) injections. METHODS: Subjects with moderate/severe IOHs, assessed using the Galderma infraorbital hollows scale (GIHS), were randomized to HAEYE injections (via needle/cannula) (Day 1+optional Month-1 touch up) or no-treatment control. Primary endpoint was blinded evaluator-reported Month-3 response, defined as ≥1-point GIHS improvement from baseline (both sides, concurrently). Other endpoints examined investigator-reported aesthetic improvement (GAIS), subject-reported satisfaction (FACE-Q™ satisfaction with outcome; satisfaction questionnaire), and adverse events. RESULTS: Overall, 333 subjects were randomized. Month 3 GIHS responder rate was significantly higher with HA-EYE (87.4%) versus control (17.7%; p<0.001), and comparable between HA-EYE-needle and HA-EYE-cannula groups (p=0.967). HAEYE GAIS responder rate was 87.5-97.7% (Months 3-12). Mean FACE-Q Rasch-transformed scores were 64.3-73.5 (HAEYE) versus 14.1-16.2 (control) through Month 12. Subjects reported looking younger (≥71%) and less tired (≥79%) with reduced under-eye shadows (≥76%) and recovered within 3-5 hours, post-treatment. Efficacy was maintained through Month 12 (63.5% GIHS responders) and through Month 18, after Month-12 retreatment (80.3% GIHS responders; 99.4% GAIS responders; FACE-Q scores: 72.5-72.8). Forty subjects (12.7%) reported typically mild adverse events (4.9% HAEYE-needle; 20.9% HAEYE-cannula). CONCLUSION: HAEYE treatment was effective in correcting moderate/severe IOHs at the primary endpoint (Month 3). Efficacy was sustained through Month 12 after first treatment for 63.5% and through Month 18 for 80.3% (after one retreatment) with needle or cannula administration. Safety outcomes were reassuring.

Development and Validation of a Photonumeric Scale for Evaluation of Infraorbital Hollowing.

BACKGROUND: The infraorbital hollow is characterized by a sunken hollowing appearance of the junction between the lower eyelid and the cheek. Dermal fillers provide a suitable option to reduce the appearance of infraorbital hollowing. To objectively evaluate treatmentrelated improvements in clinical practice and research, a validated photonumeric scale is needed. OBJECTIVE: To present the scale development methods for the Merz Infraorbital Hollow Assessment Scale and establish its reliability and clinical relevance. METHODS: A 5-point photonumeric scale was developed to objectively assess the infraorbital hollowing among subjects of varying sex, age, and skin type. Intra- and inter-rater reliability was evaluated using live assessments conducted 2 weeks apart. The clinical relevance of a 1-point difference in scale-severity grade was evaluated through side by-side comparisons of photographs with either same grade or a one-grade difference. RESULTS: The scale demonstrated excellent reliability when used by trained physicians and other healthcare practitioners. Intra-rater agreement between the 2 live-subject rating sessions was nearly perfect. Substantial inter-rater agreement between the raters from both live sessions was also demonstrated. The mean absolute difference (95% confidence interval) in scale ratings was 1.08 (1.02, 1.14) for "clinically different" pairs and was 0.34 (0.27, 0.41) for "clinically same" pairs, suggesting a 1-point difference is clinically relevant. CONCLUSION: The Merz Infraorbital Hollow Assessment Scale is a validated, reliable, and clinically relevant photonumeric scale for rating infraorbital hollowing. The scale maintains its validity and reliability with reproducible results across a diverse group of males and females of various ages and Fitzpatrick Skin Types. J Drugs Dermatol. 2023;22(1):74-81.doi:10.36849/JDD.7191.

Two-Step Skincare Regimen Addressing Aging in Three Unique Geographic Locations: A Prospective, Multi-Center, Open-Label Study.

BACKGROUND: Extrinsic factors including solar radiation and air pollution significantly impact facial skin aging. The efficacy and tolerability of a 2-step skincare regimen consisting of a vitamin C antioxidant serum (VCAS) and a 100% mineral tinted sunscreen moisturizer (TSM) were evaluated in women with hyperpigmented and photodamaged facial skin exposed to beach, mountain, and river-traversed basin city stressors. METHODS: This was an institutional review board (IRB)-approved, multi-center, prospective, open-label study involving healthy subjects. Thirty-six females aged 35 to 60 years with Fitzpatrick Skin Types I to V and exhibiting moderate to severe hyperpigmentation and moderate photodamage were recruited. The VCAS was applied to the global face twice-daily (morning and evening), and the TSM was applied in the morning with at least 2 reapplications during daily activity for 12 weeks. Clinical grading with a validated scale, standardized photography, and a self-assessment questionnaire were performed at baseline and weeks 4, 8, and 12. RESULTS: Statistically significant improvements were shown in clinically graded efficacy parameters at weeks 4, 8, and 12. Subjects showed an average improvement of 11.7%, 14.9%, and 19.1% in overall photodamage and an average improvement of 19.5%, 23.4%, and 24.5% in clarity/brightness at weeks 4, 8, and 12, respectively. Forehead lines and cheek lines demonstrated clinically significant improvement from baseline to week 12. Both products were well-tolerated and well-perceived by subjects. CONCLUSION: The 2-step skincare regimen was well-tolerated and effective in improving extrinsic signs of facial aging induced by solar radiation and air pollution stressors after 12 weeks of use. J Drugs Dermatol. 2023;22(1):16-22. doi:10.36849/JDD.7154.

Impact of DaxibotulinumtoxinA for Injection on Brow Position and Frontalis Muscle Activity Following Treatment of Glabellar Lines.

BACKGROUND: Botulinum toxin type A (BoNTA) injections for the treatment of facial lines may lead to pleasant or undesirable changes in eyebrow height and position. OBJECTIVES: The aim of this study was to evaluate the impact of glabellar injection of DaxibotulinumtoxinA for Injection (DAXI), a novel BoNTA formulation, on eyebrow position and frontalis activity. METHODS: This study involved the post hoc analysis of adult patients from the Phase 2a forehead lines (FHL, N = 60) and open-label safety (OLS, N = 175) studies who received a single dose of DAXI 40 U to the glabella and for whom facial photographs were taken at rest and at maximum eyebrow elevation. Median vertical and horizontal displacement of the brows and median forehead strain (an objective quantitative assessment of frontalis activity) from baseline to 2 weeks after glabellar DAXI injection were measured. RESULTS: Two weeks after glabellar DAXI injection, vertical eyebrow movement (at rest) of the lateral brow was observed. In both studies, vertical movement was greatest in the lateral (0.6-0.9 mm) and mid (0.5-0.7 mm) brow regions; movement in the medial brow was negligible (0-0.23 mm). In both studies, a graded reduction in forehead strain was observed 2 weeks post glabellar DAXI injection, with the greatest reduction being in the lower segment (FHL, -73%; OLS, -82%). Treatment with DAXI showed improvements in FHL wrinkle severity. CONCLUSIONS: Glabellar injection of DAXI showed a positive reduction in dynamic frontalis activity that maintained or had a positive effect on eyebrow position. Vertical movement of the brow was suggestive of an improved eyebrow shape with a mild lateral arch.

Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction.

BACKGROUND: Tapencarium (RZL-012) (5-(3.6-dibromo-9H-carbazol-9-yl)-N, N, N-trimethylpentan-1-aminium chloride) is a novel injectable synthetic molecule with cytolytic properties, capable of reducing subcutaneous fat volume. OBJECTIVES: The goal of this 3-armed, randomized, double-blind, placebo-controlled phase 2b study was to determine the safety and efficacy of low- and high-dose RZL-012 vs placebo on submental fat (SMF) reduction. METHODS: Patients (n = 151, age 18-65 years) with excess SMF received a single treatment session of RZL-012 or placebo in the submental area, after which they were monitored for 84 days. SMF was assessed at baseline and after dosing with newly developed scales, namely the Clinician Chin Assessment Tool (C-CAT) and Subject Chin Assessment Tool (S-CAT). SMF was also assessed by magnetic resonance imaging (MRI) at screening and on Day 84 after treatment. RESULTS: The proportion of patients who had a 1-grade or 2-grade improvement in C-CAT and/or S-CAT on Day 84 vs baseline was significantly higher in the high-dose RZL-012 group vs the placebo group (P < .002). The relative percentage reduction in MRI-measured SMF volume (Day 84 vs screening) was significantly greater in the high-dose RZL-012 group vs the low-dose RZL-012 or the placebo group (P < .0001). Local injection site reactions were the most common adverse events (AEs). CONCLUSIONS: A single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, patients, and MRI. From a safety perspective, there were no serious AEs and no clinically significant changes in vital signs or laboratory tests over the course of the study.

Expert Recommendations on the Use of Hyaluronic Acid Filler for Tear Trough Rejuvenation.

Restylane® Lidocaine is one of the most widely used hyaluronic acid (HA) fillers to replace lost or displaced volume during tear trough correction. Patient goals for tear trough correction include looking less tired or removing dark circles and this may be achieved by administering HA filler into the infraorbital region to correct the lower eyelid relative to the volume deficit, thereby smoothing the transition from the lower eyelid to the cheek. To achieve patient satisfaction and consistent results with Restylane, optimal application is essential; however, clinical guidance based on experience is limited. This paper reflects the recommendations of an interdisciplinary expert panel for the use of Restylane in correcting tear trough deformity, including patient selection, dosing, injection technique, and post-treatment care. Recommendations were discussed and agreed as a consensus, according to cross-sectional expertise and clinical experience. J Drugs Dermatol. 2022;21(4):387-392. doi:10.36849/JDD.6597.

Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L.

BACKGROUND: VYC-20L is a hyaluronic acid soft tissue filler with lidocaine designed to restore facial volume. OBJECTIVE: Evaluate the safety and effectiveness of VYC-20L in patients with chin retrusion. MATERIALS AND METHODS: Adults with chin retrusion were randomized (3:1) to receive VYC-20L in the chin at study onset (treatment group) or 6 months later (control group). The primary effectiveness end point was ≥1-point improvement on the Allergan Chin Retrusion Scale (ACRS) from baseline at Month 6. Safety assessments included injection site responses (ISRs) and adverse events (AEs). RESULTS: VYC-20L was administered to 192 participants (treatment group, n = 144; control group, n = 48). At Month 6, significantly more participants had an ACRS response in the treatment versus control group (56.3% vs 27.5%; p = .0019). Effectiveness was also demonstrated by the proportion of participants with improved/much improved Global Aesthetic Improvement Scale scores and responses on the FACE-Q Satisfaction with Chin questionnaire and FACE-Q Psychological Wellbeing module. Treatment benefit remained evident at Month 12. Most common ISRs were tenderness (81.1%) and firmness (75.1%). One participant (0.5%) discontinued the study due to 2 treatment-related serious AEs of facial cellulitis and injection site inflammation, both resolved without sequelae. CONCLUSION: VYC-20L significantly improved an ACRS response and was generally safe and well tolerated.

A Randomized, Controlled, Evaluator-Blinded, Multi-Center Study of Hyaluronic Acid Filler Effectiveness and Safety in Lip Fullness Augmentation.

BACKGROUND: HARK was recently approved in the US for lip augmentation and correction of upper perioral rhytids. OBJECTIVE: To demonstrate noninferiority of HARK versus a control (HAJV) in lip fullness augmentation at Week 8 after last injection (blinded evaluation). Secondary objectives were to evaluate the effectiveness and safety of HARK in lip fullness augmentation and correction of upper perioral rhytids. METHODS AND MATERIALS: Treatment with HARK or control (randomized 2:1) was administered on Day 1 in this 48-week, evaluator-blinded study with optional touch-up at Week 4. Primary endpoint was change from baseline to Week 8 in lip fullness. Secondary endpoints included lip fullness, wrinkle severity, aesthetic improvement, subject satisfaction, adverse events, and local tolerability (subject diary entries). RESULTS: The primary objective was met; HARK was noninferior to control in lip fullness augmentation at Week 8. Lip fullness and wrinkle severity improvement persisted at Week 48, and was accompanied by high aesthetic improvement and subject satisfaction scores. The mean volume of HARK injected was approximately 20% lower than control. Treatment-related adverse events and local tolerability symptoms were predominantly mild and transient. CONCLUSION: HARK was noninferior to control in lip fullness augmentation at Week 8, well-tolerated, and effective throughout this 48-week study.

The First of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines. METHODS: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as assessed by the investigator on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment of 20 U prabotulinumtoxinA (4 U/0.1 mL freeze-dried formulation injected into 5 target glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety was evaluated throughout the study. RESULTS: The 352 study patients received a median total dose of 60 U, that is, 3 treatments per year. Fifty-one patients (14.5%) experienced adverse events (AEs) assessed as possibly study drug related; 11.1% experienced study drug-related AEs after the initial treatment. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Six patients (1.7%) experienced study drug-related AEs of special interest: 3 eyelid ptosis (0.9%), 2 speech disorder (0.6%), and 1 blepharospasm (0.3%). Seven patients (2.0%) experienced serious AEs; none were study drug related. Of the 2393 samples tested, 2 patients (0.6%) tested positive for antibotulinum toxin antibodies at a single postbaseline visit. CONCLUSIONS: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was first established in this early phase II study based on a broad range of outcomes.

Treatment of Atrophic Facial Acne Scars With Microneedling Followed by Polymethylmethacrylate-Collagen Gel Dermal Filler.

BACKGROUND: Microneedling and soft-tissue filler injections have been used independently to improve acne scarring. The effectiveness of a combined approach using microneedling followed by polymethylmethacrylate (PMMA)-collagen gel has not been carefully studied. OBJECTIVE: The goal of this study was to assess the effectiveness and safety of microneedling alone versus microneedling followed by injection of PMMA-collagen gel filler for correction of atrophic facial acne scars. METHODS: We conducted a multicenter, open-label, randomized, prospective study on subjects with distensible atrophic acne scars in the face to determine whether microneedling with PMMA-collagen gel is a superior acne scar treatment over microneedling alone. Forty-four subjects received 3 microneedling treatments over a 12-week period followed by randomization to treatments with PMMA-collagen gel (treatment group) or no further treatment (control group). RESULTS: At 24 weeks, the treatment group achieved a statistically significant improvement in acne scores over microneedling alone. The improvement continued at 36 weeks. At 24 weeks, the treatment group showed a strong trend in improvement on the Physician Global Aesthetic Improvement Scale compared with microneedling alone.

Safety and Effectiveness of Repeat Treatment With VYC-15L for Lip and Perioral Enhancement: Results From a Prospective Multicenter Study.

BACKGROUND: VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine. OBJECTIVES: To evaluate safety and effectiveness of repeat treatment with VYC-15L administered 1 year after treatment for lip and perioral enhancement. METHODS: In this prospective multicenter study, 124 subjects with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) who received initial/touch-up treatment with VYC-15L received repeat treatment with VYC-15L 1 year after initial treatment. Effectiveness endpoints included LFS responder rates (≥1-point improvement from baseline) and scores on the FACE-Q Satisfaction With Lips and Appraisal of Lip Lines scales at 1 month after repeat treatment. Subjects completed safety diaries for 30 days after repeat treatment. RESULTS: LFS responder rates were 86.2%, 80.3%, and 65.3% at months 1 and 3 and 1 year, respectively, after initial/touch-up treatment. The responder rate improved to 94.3% 1 month after repeat treatment with VYC-15L and required less median volume vs initial/touch-up treatment (1.5 vs 2.6 mL). FACE-Q scores doubled from baseline at 3 months, remained high through 1 year, and doubled from baseline after repeat treatment. At 1 month after repeat treatment, 96.7% and 89.3% of subjects showed improvement over baseline in FACE-Q Satisfaction With Lips and Appraisal of Lip Lines, respectively. Severe injection site responses were less frequent after repeat treatment than initial/touch-up treatment. CONCLUSIONS: Repeat treatment with VYC-15L at 1 year was safe and effective for lip and perioral enhancement, and required less product volume to achieve similar effectiveness to initial/touch-up treatment.

Evaluation of a transparent perfluorodecalin-infused patch as an adjunct to laser-assisted tattoo removal: A pivotal trial.

BACKGROUND AND OBJECTIVE: Laser-assisted treatment of tattoos is well recognized to produce opaque epidermal whitening that prevents multiple sequential passes during a single treatment session. The amount of epidermal whitening produced in association with the procedure can be minimized by topical application of perfluorodecalin (PFD), which is an optical clearing agent. This pivotal trial assessed the ability of a transparent PFD-infused patch used in conjunction with a Q-switched nanosecond laser in the treatment of tattoos to permit multiple laser passes during a single 5 minute treatment session in comparison to the number of passes that could be completed using conventional treatment of the tattoo with the laser alone. STUDY DESIGN: Thirty subjects (mean age 37 years; 14 males) with predominantly dark blue or black tattoos were enrolled in a split-tattoo trial. One half of each tattoo was treated conventionally, whereas the other half was treated through the PFD patch. Treatments were performed using a nanosecond Q-switched 755-nm Alexandrite laser. The number of treatments performed in a 5-minute time period was quantified for each side of the tattoo (primary effectiveness outcome). Patient-reported pain scores and adverse events (AEs) were also evaluated. RESULTS: Significantly more laser passes could be made on average using the PFD patch compared with treatment using the laser alone (3.7 passes vs. 1.4 passes; P < 0.001). AEs were limited to those expected during laser removal of tattoos. The proportions of subjects with transient edema and erythema were lower in the PFD patch treatment group (36.7% vs. 63.3% and 33.3% vs. 70.0%, respectively); all AEs were transient and resolved quickly. No patient in either group exhibited dyschromia (hypo- or hyperpigmentation) in the treatment area at the 1-month post treatment visit. Additionally, when surveyed at the 1-month follow-up visit, all subjects (30/30) preferred to continue laser-assisted tattoo removal with the PFD patch. CONCLUSION: An average of 3.7 laser passes were made in a defined 5-minute treatment session when using the transparent PFD-infused patch, which is significantly more than was possible with the laser alone (average of 1.4 passes). Use of the PFD patch was associated with improved tolerability compared with conventional treatment, with subjects experiencing fewer and less severe AEs related to epidermal injury. Lasers Surg. Med. 49:335-340, 2017. © 2017 Wiley Periodicals, Inc.

Rapid, high-fluence multi-pass q-switched laser treatment of tattoos with a transparent perfluorodecalin-infused patch: A pilot study.

BACKGROUND AND OBJECTIVES: Perfluorodecalin (PFD) has previously been shown to rapidly dissipate the opaque, white micro-bubble layer formed after exposure of tattoos to Q-switched lasers [1]. The current pilot study was conducted to qualitatively determine if the use of a transparent PFD-infused silicone patch would result in more rapid clearance of tattoos than conventional through-air techniques. MATERIALS AND METHODS: Black or dark blue tattoos were divided into two halves in a single-site IRB-approved study with 17 subjects with Fitzpatrick skin types I-III. One half of each tattoo served as its own control and was treated with one pass of a standard Q-switched Alexandrite laser (755 nm). The other half of the tattoo was treated directly through a transparent perfluorodecalin (PFD) infused patch (ON Light Sciences, Dublin, CA). The rapid whitening reduction effect of the Patch routinely allowed three to four laser passes in a total of approximately 5 minutes. Both sides were treated at highest tolerated fluence, but the optical clearing, index-matching, and epidermal protection properties of the PFD Patch allowed significantly higher fluence compared to the control side. Standard photographs were taken at baseline, immediately prior to treatment with the PFD Patch in place, and finally before and after each treatment session. Treatments were administered at 4- to 6-week intervals. RESULTS: In a majority of subjects (11 of 17), tattoos treated through a transparent PFD-infused patch showed more rapid tattoo clearance with higher patient and clinician satisfaction than conventional treatment. In no case did the control side fade faster than the PFD Patch side. No unanticipated adverse events were observed. CONCLUSIONS: Rapid multi-pass treatment of tattoos with highest tolerated fluence facilitated by a transparent PFD-infused patch clears tattoos more rapidly than conventional methods.

Effect of Midfacial Volume Augmentation With Non Animal Stabilized Hyaluronic Acid on the Nasolabial Fold and Global Aethestic Appearance.

INTRODUCTION: Non animal stabilized hyaluronic acid (Perlane, Galderma, SA) was FDA approved in 2007 for the treatment of facial wrinkles and folds. Off-label use led to the observation that injection of Perlane in the midface improved both global aesthetic appearance and reduced the depth of nasolabial folds. A proof-of-concept trial was undertaken to explore this clinical observation further. METHODS: Twenty subjects with moderate midfacial volume loss and prominence of nasolabial folds underwent injection of the midface with Perlane between May and July, 2009. The average volume administered was 3.68 +/- 0.55 ml. Assessments were performed by the injecting physician and subject self-assessment for 6 months following treatment. RESULTS: 17 of 20 subjects completed all study visits. At the 6-month follow up visit 16 of 17 subjects were found to have clinically significant improvement of the midface and 14 of 17 subjects were found to have clinically significant improvement of the nasolabial folds. No serious adverse events occurred. CONCLUSION: In this early stage, proof-of-concept trial, the majority of patients treated demonstrated clinically significant, aesthetically pleasing improvement 6 months after injection of Perlane in the midface.