Prospective Clinical Trial Demonstrating the Efficacy of Hyaluronic Acid Filler for the Improvement of Atrophic Facial Scars up to 2 years.

BACKGROUND: Hyaluronic acid (HA) filler longevity has been studied for wrinkles. However, its long-term use for treating atrophic facial scars has not yet been analyzed in long-term prospective studies. OBJECTIVE: Analyze the safety and duration of a HA filler for the use in atrophic scars. MATERIALS AND METHODS: Fifteen subjects received VYC-17.5L in atrophic scars on 1 randomized cheek and saline on the other, with 1 optional touch-up treatment and crossover after the short-term trial. Grading for this long-term extension was done on Day 720, using the Global Aesthetic Improvement Scale (GAIS) and the Quantitative Global Scarring Grading System. RESULTS: On Day 720, a live blind evaluator rated the VYC-17.5L assigned side as having significant reduction in scar severity (-7.2 [t(22) = -6.01, p = .00009]) and number of scars (-8.8 [t(22) = -6.25, p = .00006]) as compared with baseline. There was no significant difference in the results from Day 120 to Day 720. Ninety-two percent (11/12) of subjects reported improvement (GAIS), were satisfied with the treatment, thought it looked natural, and had fewer side effects than expected. There were no persistent or late-onset side effects. CONCLUSION: VYC-17.5L improved rolling atrophic facial scars, and the results were sustained throughout the 2-year trial without side effects.

Long-term 23-year Global Post-marketing Safety Surveillance Review of Delayed Complications with a Supportive Hyaluronic Acid Filler for Infraorbital Hollow Rejuvenation.

HARES is a supportive (high G') HA filler with a low degree of water affinity (gel swelling) and modification (<1% BDDE) that has a well-established safety and efficacy profile in the literature, especially for infraorbital hollow (IOH) rejuvenation. To further support the safety of this product, a long-term review of delayed-onset adverse events of interest (DAEIs) related to HARES was conducted using reports from a global post-marketing safety surveillance database over the past 23 years. This review demonstrated low reporting frequencies of delayed-onset nodules and inflammatory events, establishing a long-term safety profile for HARES that supports its continued use in clinical practice, especially for IOH rejuvenation.

Randomized split-face study using a post-procedural biotech cellulose mask to improve patient comfort and downtime.

BACKGROUND: There are many post-procedural treatments touted to improve comfort and decrease downtime, but very few prospective randomized studies. AIMS: To analyze the safety and efficacy of a post-procedural biotech cellulose mask. PATIENTS/METHOD: Fifteen patients undergoing either a microneedling with radiofrequency (n = 5), non-ablative fractional (n = 5), or full erbium:YAG resurfacing (n = 5) treatment were randomized to receive a biotech cellulose mask on one side of the face for 30 min after the procedure and for 2 h a day until healed. Standardized photos and thermal images were taken 30 min after the procedure and daily until healed. The investigator and blind evaluators reviewed the photos, and subjects answered daily questionnaires. RESULTS: An analysis of the thermal images showed a significant reduction in facial temperature on the biotech cellulose mask side as compared to the control side in all groups with an average of 2.2 (range 0.2-6.5) degree Celsius reduction across all 15 subjects. All subjects reported less pain and heat immediately upon application of the mask. Thirty minutes after application, 13/15 continued to report less pain and heat, and 11/15 reported less erythema and swelling on the mask side while blind evaluators were able to choose which side had the mask 80% of the time. On average, subjects also reported significantly less swelling on Day 1 and Day 2. CONCLUSION: The biotech cellulose mask decreased patient's facial temperature, feelings of heat and pain, as well as downtime without any side effects for the subjects in this study undergoing a variety of treatments.

One-Year Data on the Longevity and Safety of Hyaluronic Acid Filler for Static Horizontal Neck Rhytids.

BACKGROUND: The long-term efficacy and safety of hyaluronic acid fillers injected into the neck have yet to be analyzed in a prospective trial in the United States. OBJECTIVE: Analyze the long-term efficacy and safety of a hyaluronic acid filler for static horizontal neck rhytids. MATERIALS AND METHODS: Twenty-six subjects were enrolled in the study. Six subjects were randomized to receive saline and 20 subjects were randomized to receive HA RR. All subjects were randomized to use a cannula on 1 side and needle on the other with optional retreatment on day 30 and optional crossover treatment with different assignment on day 60. The subjects were graded using the Transverse Neck Line Scale, Canfield photography, and the Global Aesthetic Improvement Scale on day 360. RESULTS: A significant improvement from baseline on day 360 was achieved on the Transverse Neck Line Scale according to the blind evaluator, subjects, and investigator without any delayed-onset or prolonged side effects. There was no significant difference in the average improvement from the short-term analysis on day 60 to the long-term analysis on day 360. CONCLUSION: HA RR achieved significant long-term improvement in static horizontal neck rhytids without any long-term side effects.

Arterial Wall and Tissue Penetration Force With Various Cannulas and Needles.

BACKGROUND: Vascular penetration during aesthetic filler injections can cause serious side effects such as skin necrosis and blindness. OBJECTIVES: The objective of this study was to analyze the effect of cannula brand and gauge on the risk of vascular penetration. METHODS: The minimal force to penetrate the superficial temporal artery with 3 cannula brands and 1 needle brand in 4 sizes (22, 25, 27, and 30 gauge) was measured in 4 fresh frozen cadavers utilizing a force gauge that measured as low as 0.1 Newtons. Tissue penetration force in the subdermal plane of the nasolabial fold was measured and compared with retrospective training data in live humans. The arterial penetration test was repeated at a second site on 1 fresh cadaver with 2 different force gauges. RESULTS: Significantly lower forces were needed with all size needles vs the same gauge cannulas in all brands to penetrate the cadaveric artery and advance in the subdermal plane of the nasolabial fold in both cadavers and live humans. To successfully enter the artery in a cadaver with any cannula, numerous attempts were necessary. The tissue penetration force in the subdermal plane of the nasolabial fold in a cadaver was not significantly different than in a living person; however, it was significantly higher than the arterial penetration force in a dissected cadaver. CONCLUSIONS: All gauge cannulas (including 27 and 30 gauge), require more force than the same size needle to penetrate an artery. However, it appears that friction coefficient and flexibility, not the arterial penetration force, are the most important factors in keeping the instrument outside the vessel.

Review of Botulinum Toxin Uptake and Novel Theory Regarding Potential Spread Days After Injection.

Although most clinicians agree that diffusion of botulinum neurotoxin (BoNT) occurs, its extent, timeline, and clinical importance have been debated. A literature search on PubMed (National Institutes of Health, Bethesda, MD) was done up to January 15, 2023, which included the following search terms: botulinum toxin A uptake; botulinum toxin A diffusion; and botulinum spread. A total of 421 publication titles were found and analyzed. Based on titles, the author selected 54 publications as potentially applicable and reviewed each 1 in depth, along with its supporting references. There are several publications that support a novel theory that small amounts of BoNT can remain in the area days after injection and spread to adjacent muscles. Although current thinking is that BoNT is completely taken up within hours, making its spread days after injection of BoNT not a plausible theory, the following literature review and case report support a novel theory.

A split-face, blind, randomized placebo-controlled clinical trial investigating the efficacy and safety of hyaluronic acid filler for the correction of atrophic facial scars.

BACKGROUND: Hyaluronic acid fillers have been studied extensively for facial wrinkles; however, their efficacy for atrophic facial scars has yet to be analyzed in a prospective placebo-controlled study. OBJECTIVE: To analyze the efficacy and safety of a hyaluronic acid filler for atrophic facial scars. METHODS & MATERIALS: Fifteen subjects were randomized to receive up to 1 ml of VYC-17.5 L on one cheek and up to 1 ml of saline on the other side, with an optional touch-up treatment. Subjects were graded by a live blind evaluator using the Quantitative Global Scarring Grading System (QGSGS) (J Cosmet Dermatol. 2006;5:48), the Global Aesthetic Improvement Scale (GAIS), and Canfield photo-analysis. RESULTS: According to the blind evaluator, there was a significant reduction 90 days after the last treatment on the QGSGS for VYC-17.5L compared with saline (-6.6 VYC-17.5L vs -1.7 saline [t(28) = -4.3196, p = 0.008]). There was a smaller, but still significant reduction on the QGSGS for saline alone (10.4 to 8.6 [t(14) = -3.453, p = 0.004]). In addition, 93% (13/14) of subjects chose VYC-17.5L over saline treatment and reported an improvement on the GAIS. There were no serious side effects and all minor side effects resolved by Day 30. CONCLUSION: VYC-17.5L achieved significant improvements in rolling atrophic scars as compared to saline, though saline also had modest improvements.

A Retrospective Review of the Safety and Efficacy of Low-dose Triamcinolone Mixed with Hyaluronic Acid Fillers to Reduce Post-injection Infraorbital Swelling.

Objective: This retrospective review assesses the efficacy and safety of low-dose triamcinolone (1mg/cc) added to hyaluronic acid fillers to decrease swelling after infraorbital injection. Methods: This retrospective analysis includes 447 patients who underwent 706 infraorbital hyaluronic acid filler treatments from April 2013 to March 2020 by a single injector. Short-term post-procedural swelling (≤2 weeks) was assessed through follow-up phone calls, which were documented in patient charts. The effect of triamcinolone, filler type, volume, and patient characteristics on the rate of post-procedure swelling were analyzed. Results: Swelling after infraorbital hyaluronic acid filler occurred in over half of the patients (51%, 103/202), but significantly decreased (23%, 29/124) when 1mg/cc of triamcinolone was mixed with the filler (x2[1, N=326]=24.296, p<0.00001). The incidence of swelling was directly correlated with the amount of hyaluronic acid filler injected (37% ≤ 0.55cc, 51% 0.56-1cc, and 60% >1cc) [x2[1, N=95]=3.9231, p=.048]. There was no significant difference in patient age, sex, Fitzpatrick skin type, or history of allergies on incidence of post-procedure swelling. Adverse events were limited to expected injection-site reactions, and there were no reports of hypopigmentation or atrophy from the addition of triamcinolone. Limitations: This is a retrospective study that used patient reporting for short-term post procedure swelling. Conclusion: This is the first retrospective study showing the safety and efficacy of a novel technique adding low-dose triamcinolone (1mg/cc) to hyaluronic acid filler to reduce post-procedure swelling within the first few weeks following infraorbital injection. Additionally, using lower volumes is also effective at reducing post-procedure swelling. Larger, randomized, controlled trials are needed to support our findings.

Infraorbital Hyaluronic Acid Filler: Common Aesthetic Side Effects With Treatment and Prevention Options.

Background: Infraorbital hollows can give a fatigued or aged appearance, which can be treated by volumizing the segmented transition from the tear trough to the cheek with hyaluronic acid filler. Due to thin skin and the complex anatomy of the infraorbital area, both short- and long-term side effects (SEs) from this treatment are very common. While some patients are clear surgical candidates vs filler candidates, in real-world practice, many, if not most, patients are on a continuum where either procedure is appropriate, and the treatment decision is individualized based on each person's risk vs benefit profile. Objectives: Common aesthetic SEs from hyaluronic acid filler treatment in the infraorbital area will be reviewed, including their etiology, prevention, detection, and treatment. Methods: The author's experience from injecting the infraorbital areas of more than 800 patients in private clinical practice and observations from both short- and long-term follow-ups over 8 years is leveraged to provide detailed guidance. Results: Recommendations on injection techniques, patient selection, and patient education are presented along with algorithms for the prevention and management of bruising, short- and long-term swelling, bumps, and blue discoloration (which is usually secondary to swelling from the filler rather than just the filler alone placed or migrating too superficially). Conclusions: For nearly all patients, complete dissolution of filler with hyaluronidase is not required to address the issue, and the guidelines provided here will assist clinicians in the management of SEs to increase patient satisfaction with their treatment and aesthetic outcome.

A Randomized, Placebo-Controlled, Split-Neck Trial of Hyaluronic Acid Filler for Static Horizontal Neck Rhytides Using Either a Cannula or Needle.

BACKGROUND: Hyaluronic acid (HA) fillers have been studied extensively on the face; however, their safety and efficacy on the neck has not yet been evaluated in a prospective trial in the United States. OBJECTIVE: Analyze the efficacy and safety of a HA filler for static horizontal neck rhytides using either a cannula or needle. MATERIALS AND METHODS: Twenty-six subjects were randomized to receive up to 1 mL of the HA filler Restylane Refyne (HARR, n = 20) or saline (n = 6) using a cannula on one side and a needle on the other with optional repeat treatment. Subjects were graded using the Transverse Neck Line Scale, Canfield photography, and the Global Aesthetic Improvement Scale. RESULTS: A significant improvement 30 days after the last treatment was achieved on the Transverse Neck Line Scale when comparing HARR with saline according to the blind evaluator, subjects, and investigator without any significant side effects. In addition, the blind evaluator, subjects, and investigator rated the side of the neck injected with a needle as having significantly greater improvement than the cannula. CONCLUSION: The hyaluronic acid filler, Restylane Refyne, achieved significant improvement in static horizontal neck rhytides using either a cannula or needle without any serious side effects, although the needle was more effective.

Intense Pulsed Light as a Treatment for Senile Purpura: A Pilot Study.

BACKGROUND AND OBJECTIVES: Senile purpura is a common condition characterized by recurrent ecchymoses in the elderly on the extensor surfaces of the forearms, hands, and legs. Our objective is to assess the efficacy and safety of a protocol using intense pulsed light (BBL; Sciton Inc., Palo Alto, CA) to improve the appearance of senile purpura on subjects' extensor forearms. STUDY DESIGN/MATERIALS AND METHODS: Five subjects over 65 years of age, with ecchymotic lesions measuring over 1 cm on each forearm and five younger subjects under 35 years of age, without any ecchymotic lesions, were included in the study. The subjects were treated on one randomized forearm with a new intense pulsed light protocol for four weekly sessions. Photographs and subject questionnaires were taken weekly before each treatment as well as 1 month after all treatments. Skin biopsies were taken 1 day after the last of four weekly treatments. Histological analysis, including hematoxylin and eosin, elastic van Gieson, and Masson's Trichrome staining, were carried out to assess both the epidermal thickness and dermal connective tissue structure. The protocol consists of multiple passes using an intense pulsed light (BBL; Sciton Inc.) device in which the wavelength, filter, and fluence are adjusted for each step. Step 1 uses infrared light (800-1,400 nm), high intensity, a smooth adapter, and a constant motion technique. Step 2 employs a 590-nm filter with two different fluences and step 3 utilizes a 560-nm filter. The fluence of steps 2-3 is increased by 1 J each treatment if no side effects are noted. RESULTS: Using a new intense pulsed light protocol in subjects with senile purpura, both the number and square area of ecchymoses on the treated arm were significantly reduced (P = 0.02 and P = 0.04, respectively, paired t test) as compared with the untreated arm at 1 month after four weekly treatments. Despite this pilot study including challenging cases of subjects on both inhaled and injected corticosteroids and blood thinners, all subjects with senile purpura had at least a 50% reduction in the total square area of their ecchymoses on their treated arm. There were no significant or long-lasting side effects, and all subjects reported satisfaction with the treatment with a desire to continue treatments on their control arm. Blinded evaluators were able to select 100% of the time in the subjects with senile purpura, which was the treated arm as compared with the control arm when reviewing photographs from 1 month after the last treatment. In addition, several subjects were noted to have a significant improvement in the appearance of hemosiderin deposition and photodamage. Histologically, intense pulsed light treatments significantly increased epidermal thickness in elderly subjects by 21.14% (P = 0.0153, two-tailed, paired t test), to levels comparable with young subjects. Such restoration is consistent with the other histological observations by blinded evaluators of more abundant and organized collagen fibers in the dermis and reduced aggregates of disorganized elastin fibers. CONCLUSION: This new intense pulsed light protocol is safe and effective in improving the clinical appearance of senile purpura as well as preventing future lesions by improving the structure of the skin by increasing epidermal thickness and improving collagen and elastic fiber morphology. The treatment was well-tolerated, adverse effects were minimal, and there was high patient satisfaction. Lasers Surg. Med. 2020. © 2020 Wiley Periodicals LLC.

Zosteriform lymphangioma circumscriptum.

Lymphangioma circumscriptum (LC) is a form of lymphangioma involving skin and subcutaneous tissue. It is evident as translucent vesicles of varying size, though commonly 2 to 4 mm, and of a pink, red, or black hue. It is localized to the dermis, frequently extending deeply and laterally. LC may resemble other entities, such as metastatic carcinoma of the skin, lymphangiectasis, or herpes zoster. We report an unusual verruciform, zosteriform form of LC.

Utility of age, gender, ANA titer and pattern as predictors of anti-ENA and -dsDNA antibodies.

Monovariate and multivariate analyses including logistic regression were performed to determine associations among predicting variables [age, gender, immunofluorescence pattern, and anti-nuclear antibody (ANA) titer] and anti-extractable nuclear antigen (ENA) and -dsDNA antibodies (Abs) in 1089 patients with positive fluorescent ANA (FANA) test results. Samples with high titer ANAs had an increased frequency of anti-ENA and -dsDNA Abs. The receiver operating (ROC) curves of the ANA titer for anti-ENA Abs had a larger under the curve area compared to the ROC curve for anti-dsDNA Abs, indicating that ANA titer is better for predicting anti-ENA Abs than anti-dsDNA Abs. There was no relation noticed between immunofluorescence patterns and anti-ENA and -dsDNA Abs except an increased frequency of anti-dsDNA Abs found in samples with a homogeneous pattern. Probability calculations on the basis of the ANA pattern and the titer showed that samples with low titer ANAs (1:160 or less) had low probabilities for anti-ENA Abs (0.002-0.009) regardless of immunofluorescence patterns. However, samples with a homogeneous pattern at any titers including low titers had high probabilities for anti-dsDNA Abs. A decreased frequency of anti-dsDNA Abs as measured by Crithidia assay was noticed in samples from patients aged 50 or older. In contrast, no association was noticed between age and anti-ENA Abs. There was no female preponderance found in the presence of anti-ENA and -dsDNA Abs. In conclusion, our study shows that the ANA titer but not the immunofluorescence pattern is useful in predicting anti-ENA Abs. In contrast, both the ANA titer and the immunofluorescence pattern help in predicting anti-dsDNA Abs. Samples with low titer ANAs (1:160 or less) may not need a further test for anti-ENA Abs unless an ANA-associated disease is highly suspected. However, a test for anti-dsDNA Abs should be considered in samples with a homogeneous pattern at any titer including low titers.

Brief report: parental reporting of regression in children with pervasive developmental disorders.

Information on age and nature of the onset of autism and other developmental disorders was obtained through review of parent completed developmental history; in addition information on the child's early development, diagnostic information, and information on parent characteristics was also obtained. In this relatively large series of cases the parents of children with autism were more likely than parents of children with other developmental disorders to report possible loss of developmental skills. However, the question of actual skill loss was complicated since in some cases parents also had reported even earlier developmental delays or a pattern more of developmental stagnation than clear loss of abilities. Only a few children exhibited a clear and unequivocal loss of developmental skills.