Effectiveness of Volbella (VYC-15L) for Infraorbital Hollowing: Patient-Reported Outcomes From a Prospective, Multicenter, Single-Blind, Randomized, Controlled Study.

BACKGROUND: Infraorbital hollowing can be addressed with hyaluronic acid soft tissue fillers. A prospective, multicenter, evaluator-blinded, randomized, controlled study (NCT03418545) demonstrated the safety and effectiveness of Juvéderm Volbella XC (VYC-15L, Allergan Aesthetics, an AbbVie company, Irvine, CA) in adults seeking correction for infraorbital hollows. OBJECTIVE: The objective of the current analysis was to examine patient-reported outcomes from the clinical study. METHODS: Participants were randomly assigned 3:1 to the VYC-15L treatment group or the no-treatment control group. Outcome measurements included: evaluating investigator (EI)- and participant-assessed Global Aesthetic Improvement Scale (GAIS) scores, as well as participant responses to the FACE-Q Appraisal of Lower Eyelids, questions on treatment satisfaction, the extent to which patients were bothered by dark circles under their eyes, and willingness to recommend treatment to a friend. RESULTS: The modified intent-to-treat population included 135 participants (median age, 47 years; 91.9% female). At Month 3, the majority of VYC-15L-treated participants showed improvements in the EI- and participant-assessed GAIS. The mean change from baseline to Month 3 score (32.7% increase) showed statistically significant improvement (mean [standard deviation], 17.8 [19.8], P < .0001). At Months 3 and 12 posttreatment, most VYC-15L-treated participants reported feeling satisfied with treatment and not feeling moderately or very bothered by dark circles under their eyes, and would recommend treatment to a friend. CONCLUSIONS: The current analysis demonstrated the effectiveness of VYC-15L treatment to reduce infraorbital hollowing and to improve overall satisfaction based on validated patient-reported outcomes. Participant-assessed improvements aligned with EI-assessed outcomes and lasted for 1 year.

A Prospective, Multicenter, Single-Blind, Randomized, Controlled Study of VYC-15L, a Hyaluronic Acid Filler, in Adults for Correction of Infraorbital Hollowing.

BACKGROUND: Rejuvenation of the under-eye area is a popular facial aesthetic treatment option. OBJECTIVES: This study evaluated the safety and effectiveness of VYC-15L for the correction of moderate or severe infraorbital hollowing. METHODS: This was a randomized, controlled, single-blind study with a primary endpoint defined as the proportion of participants with ≥1-grade improvement at Month 3 assessed by an evaluating investigator employing the Allergan Infraorbital Hollow Scale. Three-dimensional imaging was conducted to assess infraorbital volume up to Month 12. Procedure pain and injection-site responses (ISRs) were documented, and safety was monitored throughout the study. RESULTS: At Month 3, the difference between treatment (83.1%) and control (15.6%) was 67.5% (95% CI = 52.9 to 82.0, P < 0.0001). 3D imaging showed a mean volume increase from baseline of 0.733 mL (left) and 0.777 mL (right) at Month 12. Mean pain scores were ≤1.7 (scale of 0 to 10). Most ISRs with initial treatment were mild/moderate and resolved in ≤1 week, including tenderness (49.5%), bruising (42.7%), and swelling (41.7%). Thirty-four participants had treatment-emergent adverse events (TEAEs), of which 14 (10.3%) had treatment-related TEAEs, including bruising (3.8%) and swelling/edema (2.9%), which resolved in ≤2 weeks. Three participants had swelling/edema starting >30 days posttreatment; 2 resolved in ≤4 days, 1 by 45 days. No treatment-related serious AEs were reported. CONCLUSIONS: VYC-15L was safe and effective for the correction of moderate or severe infraorbital hollowing and lasted through 1 year.

Evaluating the Safety and Efficacy of a Topical Formulation Containing Epidermal Growth Factor, Tranexamic Acid, Vitamin C, Arbutin, Niacinamide and Other Ingredients as Hydroquinone 4% Alternatives to Improve Hyperpigmentation: A Prospective, Randomized, Controlled Split Face Study.

Hyperpigmentation is a common concern of patients in aesthetic practice. There are various treatment options, but topical depigmenting agents such as hydroquinone (HQ) are usually a first-line option. Given HQ's side effects and potential controversy over its long-term use from prior animal studies, there is a consumer demand for non-HQ topical formulations that provide similar efficacy, but with a reduced adverse reaction profile to HQ. There is increasing evidence to support the use of selective growth factors, tranexamic acid, niacinamide, arbutin, and Vitamin C in improving hyperpigmentation. This study sought to determine whether a non-HQ topical formulation, composed of the aforementioned ingredients, could provide similar or improved efficacy to topical HQ, but with a reduced adverse reaction profile. This single-center, prospective, randomized, controlled split face study investigated the safety and efficacy of a proprietary product SKNB19 compared with hydroquinone 4% (HQ4%) in treating hyperpigmentation. Eighteen adult subjects with facial pigmentation were randomly assigned to have one side of their face treated with SKNB19 twice a day (morning and night application) and the other treated with HQ4% applied nightly. Patients used a 5-point scale to self-assess their overall appearance, and a 4-point scale to assess redness, irritation, and tolerability to the skin-brightening creams. A Wilcoxon signed-rank test was used to test whether there was a statistical difference between the two treatments. Three-dimensional imaging was performed before treatment was administered and again 1 month following treatment initiation using a Canfield Vectra 3D imaging system. Five independent reviewers comprising two dermatologists, two facial plastic surgeons, and one oculoplastic surgeon graded and performed a qualitative comparative assessment of each side of the face using the before and after images. A Wilcoxon signed-rank test was used to test whether there was a statistical difference in overall appearance between SKNB19- and HQ4%-treated sides. SKNB19-treated hyperpigmentation had a statistically significant improvement in the overall appearance of hyperpigmentation and was shown to be 28.5% better than HQ4%-treated skin in the patient self-assessment and 27% better than HQ4%-treated skin in the independent reviewer assessment. On pair-wise comparison, the independent reviewer assessment also showed that 88.2% of the SKNB19-treated sides appeared equal or better than the HQ4%-treated sides. One patient dropped out of the study because of severe intolerance to HQ4%. No patients experienced intolerance to SKNB19, and all were able to continue its use without adverse effects. SKNB19-treated hyperpigmentation also had a statistically significant reduction in irritation when compared with HQ4%-treated hyperpigmentation. Patients reported a reduction in redness when using SKNB19 as opposed to HQ4%, but these figures did not reach statistical significance. This study supports that SKNB19, a recently developed non-HQ proprietary product, is safe and effective in improving hyperpigmentation. SKNB19 significantly improved the appearance of hyperpigmentation when compared with HQ4% in both patient self-assessment and independent reviewer assessment. SKNB19 exhibited a lower adverse reaction profile and was significantly better tolerated than HQ4%. SKNB19 should be considered as a safe and effective non-HQ alternative for the management of hyperpigmentation.

Safety/Efficacy of New Topical Silicone Formulation with Selective Growth Factors for Treating Striae Distensae.

Striae distensae (SD) are linear dermal scars that arise from progressive stretching or tearing of the dermal layer. This study tests the safety and efficacy of a topical formulation of silicone-based scar cream containing selective synthetic recombinant human growth factors, hyaluronic acid, and vitamin C to improve overall appearance and texture of SD. Twenty-two subjects with SD alba were recruited and randomized to apply the topical formula to half of their SD laterally twice a day for 1 month. Patient surveys were obtained at 1 month for overall appearance, texture, and tolerability. Three-dimensional imaging was obtained at baseline and at 1 month and submitted to independent evaluators for grading on overall appearance. Subjects reported improved texture and appearance in 86.4% of SD. Subjects reported 100% of untreated SD to have no change in overall appearance or texture. 90.9% of subjects reported no tolerability issues. 9.1% of the treated group reported mild issues such as slight itching or redness the first day of application, which subsided in 2 days for all patients. Independent evaluators indicated improvement in 72.7% of SD in comparison to improvement in 36.3% of untreated SD. This study demonstrates that the investigated topical formulation is safe and effective to use for SD.

Gene expression analysis in scars treated with silicone cream: a case series.

BACKGROUND: In contrast to fetal scar tissue, adult scar tissue presents with visible scarring. Topical silicone creams have been shown to improve the appearance of scars. This case series compares the genetic expression of post-surgical scar tissues that received topical scar treatment with silicone cream, SKN2017B, or no treatment. SKN2017B is a recently formulated silicone-based scar cream that contains selective synthetic recombinant human growth factors, hyaluronic acid, and vitamin C. We hypothesise that scars treated with silicone-based scar creams have a more favourable genetic expression resembling a well-healing scar. METHODS: Women who had undergone an abdominoplasty were included in this investigation and randomly assigned to treat part of the scar with topical silicone, another part with SKN2017B, and to leave a third part untreated. After four weeks, punch biopsies were taken and the RNA sequenced. Healthy abdominal skin was biopsied as baseline data. Genes of interest were identified and median values were calculated for the samples. RESULTS: SKN2107B-treated scars demonstrated the lowest collagen type I to collagen type III ratio. Other key genes of interest in wound healing showed the lowest (favourable) expression of fibroblast activation protein alpha, lysyl oxidase and cartilage oligomeric matrix protein; the highest (favourable) expression of fibronectin type III domain containing 1 and matrix metallopeptidase 9 were found in scars treated with SKN2017B. CONCLUSION: The results of this small case series demonstrate a trend that those scars treated with topical silicone cream, notably SKN2017B, display the most favourable gene expression for wound healing.

Silicone-Based Scar Cream for Post Upper Eyelid Blepharoplasty-associated Cicatricial and Hypertrophic Scarring

PURPOSE: Silicone cream has been shown to improve the appearance of postoperative scars. Nevertheless, surgeons may incorporate intralesional wound modulators such as a triamcinolone and/or 5-fluorouracil (5-FU) for scars that do not completely heal well or those that do not completely respond to other treatment options such as silicone cream. This study sought to determine whether a silicone-based topical scar cream that incorporates selective growth factors can help reduce the incidence of postoperative cicatricial and hypertrophic changes in upper eyelid blepharoplasty incisions. METHODS: This is a single-surgeon, retrospective chart review of patients that underwent a cosmetic upper eyelid blepharoplasty. Subjects were divided into two cohorts depending on whether they received postoperative topical scar cream (SKN2017B) twice daily for 3 months versus no topical scar treatment. Using a modified Vancouver Scar Study Scale for treatment criteria, the incidence of focal intralesional injections of triamcinolone and 5-FU to targeted areas of cicatricial and hypertrophic changes was compared between the two groups. RESULTS: 272 eyelids were identified, of those, 132 eyelids received no treatment and 140 were treated with SKN2017B. 43.9% of eyelids that did not receive treatment underwent intralesional injections of triamcinolone and 5-FU, and 22.9% of eyelids treated with SKN2017B underwent intralesional injections of triamcinolone and 5-FU. The difference between the two groups was found to be statistically significant (P less than 0.05). No adverse reactions were reported from either group. CONCLUSION: The use of a topical silicone-based scar cream has been shown to be safe and effective in decreasing the incidence of intralesional injections of triamcinolone and 5-FU for postoperative cicatricial and hypertrophic changes in upper eyelid blepharoplasty incisions. J Drugs Dermatol. 2019;18(5):440-446.

Safety and Efficacy of a Scar Cream Consisting of Highly Selective Growth Factors Within a Silicone Cream Matrix: A Double-Blinded, Randomized, Multicenter Study.

BACKGROUND: Several growth factors and hyaluronic acid are implicated in fetal scarless healing. Whether these factors can be applied to an adult scar to improve scar characteristics is unknown. OBJECTIVES: This study compared the efficacy and safety of SKN2017B, a proprietary topical cream consisting of selective synthetic recombinant human growth factors and hyaluronic acid in a silicone base containing a specifically formulated silicone cream for postsurgical scar treatment. METHODS: In this prospective, randomized, controlled, double-blinded study, unilateral or bilateral facial or truncal scars in adult surgical patients were randomly treated with SKN2017B or silicone cream. Study investigators, study patients, and 2 independent reviewers assessed improvement in scar characteristics after 4 and 12 weeks of treatment. RESULTS: Forty-nine bilateral and 12 unilateral scars in 45 patients were treated with SKN2017B or silicone. At 12 weeks, investigators rated 74% of scars treated with SKN2017B as showing overall improvement vs 54% of silicone-treated scars, a 73% relative improvement with SKN2017B (P < 0.0001). Patients rated a moderate-to-significant improvement in 85% of SKN2017B-treated scars vs 51% of silicone-treated scars, a 67% relative improvement with SKN2017B (P < 0.001). Independent reviewers rated 87% of scars treated with SKN2017B to be better overall vs 1% of scars treated with silicone (P < 0.0001). There were no tolerability issues or adverse reactions with either cream. CONCLUSIONS: SKN2017B consists of highly selective growth factors within a silicone cream matrix and is well tolerated and effective for surgical scar management.

Managing Periocular Filler-Related Syndrome Prior to Lower Blepharoplasty.

BACKGROUND: Hyaluronic acid (HA) fillers are extensively used in periocular volume augmentation. Although they have an excellent safety profile, filler-related issues such as visibility/palpability, contour abnormalities, malar edema, and blue-gray dyschromia can occur. Recognition and management of filler-related issues are critical prior to subsequent procedures. The clinical course of patients who had periocular HA filler-related issues and subsequently underwent lower eyelid blepharoplasty is described. METHODS: HA filler was dissolved with hyaluronidase (15-30 U/cm2) treatment. Visible lower eyelid fat prolapse after filler removal was corrected with transconjunctival blepharoplasty with fat repositioning and skin resurfacing. Complications and outcome were assessed and recorded. RESULTS: Twenty-three patients (46 eyelids) were treated. All presented with contour abnormalities, 19 with contour abnormalities and malar edema, and seven with blue-gray dyschromia. In 15 patients, one session of hyaluronidase completely dissolved the filler, and in eight patients, two sessions were required. Of these eight patients, edema resolved after the second hyaluronidase injection in four; in the remaining four, mild edema persisted despite absence of visible/palpable filler. Postblepharoplasty, 19 patients had an acceptable outcome with no complications (82.6%). Four patients had prolonged edema postoperatively; three had a resolution by 6 months. In 23 patients who had skin resurfacing procedures, there was no incidence of postinflammatory hyperpigmentation. CONCLUSIONS: HA filler-related issues need to be identified and managed prior to further intervention. Hyaluronidase treatment effectively dissolves the filler, but mild malar edema can persist. Outcomes are acceptable after subsequent blepharoplasty, but adequate patient counseling is necessary about expectations and limitations. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Topical Agents for Scar Management: Are They Effective?

Scar formation is the body's natural healing response to reestablish dermal integrity following an injury. Excessive scarring, however, can cause significant cosmetic, functional, and psychological problems. A wide variety of topical creams, lotions, and oils are available for scar treatment or wound healing. Sieving through the options and selecting the best option for their patients can be challenging for clinicians, especially given that clinical evidence for many of the active agents in commonly used topical treatments is lacking. The goal of this review is to provide an overview of topical treatments utilized for scar management, including their mechanism of action and evidence of efficacy. As knowledge of the wound healing process is critical to understanding the effects of topical treatments, the pathophysiology of wound healing is also reviewed.

J Drugs Dermatol. 2018;17(4):421-425.

Simplifying Blepharoplasty.

Blepharoplasty remains one of the most common aesthetic procedures performed today. Its popularity stems partly from the ability to consistently make significant improvements in facial aesthetics with a relatively short operation that carries an acceptable risk profile. In this article, the authors attempt to simplify the approach to both upper and lower lid blepharoplasty and provide an algorithm based on the individual findings for any given patient. The recent trend with both upper and lower lid blepharoplasty has been toward greater volume preservation and at times volume augmentation. A simplified approach to upper lid blepharoplasty focuses on removal of excess skin and judicious removal of periorbital fat. Avoidance of a hollow upper sulcus has been emphasized and the addition of volume with either fat grafting or fillers can be considered. Lower lid blepharoplasty can use a transcutaneous or a transconjunctival approach to address herniated fat pads while blending the lid-cheek junction through release of the orbitomalar ligament and volume augmentation with fat (by repositioning and/or grafting) or injectable fillers. Complications with upper lid blepharoplasty are typically minimal, particularly with conservative skin removal and volume preservation techniques. Lower lid blepharoplasty, conversely, can lead to more serious complications, including lid malposition, and therefore should be approached with great caution. Nevertheless, through an algorithmic approach that meets the needs of each individual patient, the approach to blepharoplasty may be simplified with consistent and predictable results.

Modified full-thickness blepharotomy for treatment of thyroid eye disease.

PURPOSE: Upper eyelid retraction is the most common sign of thyroid eye disease (TED). The results of traditional surgical procedures to correct upper eyelid retraction have been limited by unreliable postoperative eyelid height and contour. We investigate the outcome of the surgical correction of upper eyelid retraction using a modification of the full-thickness blepharotomy technique initially described by Elner et al. METHODS: Fifty-three patients (78 eyelids) underwent a modified full-thickness blepharotomy. RESULTS: Symmetry (within 1 mm) was achieved in 40 patients (75.5%) and symmetry (within 2 mm) was achieved in 43 cases (81.1%). Of the 53 patients, 8 (15.1%) required reoperation. CONCLUSIONS: Our surgical approach can be performed efficiently and produces predictably satisfactory eyelid height even in severely retracted eyelids.

Signet cell adenocarcinoma of the rectum metastatic to the orbit.

A 24-year-old man developed abdominal carcinomatosis from signet cell carcinoma of the rectum. His only distal metastasis involved the superior orbit. Orbital pathology showed signet cells with a characteristic immunopathologic pattern. No hereditary syndrome was found. The authors identified only 5 cases in the literature describing colorectal adenocarcinoma metastatic to the orbit, with 2 showing histopathology. The authors believe that this rare case represents the first illustrating bona fide signet cell colorectal cancer involving the orbit.

Orbital dissemination of Lemierre syndrome from gram-positive septic emboli.

A 45-year-old patient presented with bilateral orbital abscesses. He was found to have Lemierre syndrome, a condition involving septic thrombophlebitis of the internal jugular vein. The patient developed severe proptosis, sepsis, and cavernous sinus thrombosis. Despite aggressive antibiotic and anticoagulation therapy, visual loss was rapid, and the patient ultimately died. Lemierre syndrome, previously thought to be rare, is now becoming more commonly reported. Its prompt diagnosis and treatment are essential for patient survival.

Evaluation of the canalicular entrance into the lacrimal sac: an anatomical study.

PURPOSE: The purpose of this study was to investigate the prevalence of a common canalicular entrance in the lacrimal sac and to investigate the anatomy of the canalicular/lacrimal sac junction with direct visualization using a novel cadaveric dissection technique. METHODS: Preserved cadavers were dissected to allow direct visualization of the canalicular entrance(s) to the lumen of the lacrimal sac. The prevalence of a common canaliculus and the anatomical variations of the canalicular/lacrimal sac mucosal fold of tissue were recorded. RESULTS: One hundred twenty-four lacrimal systems (95 cadavers; 43 female, 52 male) were included in the study analysis. Overall, 123 lacrimal systems demonstrated a common canaliculus entering the lacrimal sac. Only one demonstrated 2 separate orifices (right orbit; male) in the sac (0.08%; 95% confidence interval, 0.1%-4.4%). Seventy-four lacrimal systems had some variation of a canalicular/lacrimal sac mucosal fold (59.7%). The remaining 50 (40.3%) had no visible canalicular/lacrimal sac mucosal fold. CONCLUSIONS: This study provides direct anatomical evidence that the prevalence of separate canalicular orifices in the lacrimal sac is lower than previously reported (<1%). Additionally, the presence of a valve-like structure at the canalicular/lacrimal sac junction is common. These observations can potentially play a role in evaluating and treating lacrimal system pathology.

Correlation between extraocular muscle size and motility restriction in thyroid eye disease.

PURPOSE: Evaluate the relationship between extraocular muscle (EOM) size, measured by computed tomography, and ocular motility in thyroid eye disease (TED). METHODS: This case series is based on a retrospective review of the records of 54 patients (108 orbits) with TED. Main outcome measures included EOM size and degree of motility restriction. The average diameter of each rectus muscle was compared with published norms. Four subpopulations based on Age (< 40 or ≥ 40 years) and State of thyroid eye disease (active or stable) were studied. Versions were measured by the corneal light reflex method. The trend of muscle diameter versus motility restriction was evaluated. RESULTS: The average EOM diameter was greater than the norm in the study cohort and 4 subpopulations. The average diameter was largest in the Older and Active TED subpopulations. The inferior rectus and medial rectus were most frequently restricted in the study cohort and 4 subpopulations. The medial rectus had the strongest trend between increasing diameter and motility restriction, followed by the inferior rectus and the superior muscle group (comprised of the superior rectus and levator palpebrae superioris). However, there was a general lack of strong correlation between the diameter of the rectus muscles and their respective motility, especially in the Younger subpopulation. CONCLUSION: EOM diameters are larger and have more restricted motility in the Older and Active TED subpopulations. Contrary to prior publications, the correlation between EOM diameters and motility was weak, especially in the Younger subpopulation. These findings suggest that the pathophysiology of EOM enlargement is different based upon the age of the patient and the activity of the orbitopathy.

Dedifferentiated adenoid cystic carcinoma of the lacrimal gland.

A rare variant of adenoid cystic carcinoma is the dedifferentiated sarcomatoid form, which has previously been reported in the hard and soft palate, maxillary sinus, submandibular glands, and nasal cavity. The authors report the first case of a dedifferentiated sarcomatoid adenoid cystic carcinoma occurring in the lacrimal gland, that of a 52-year-old man. The patient presented with a 4-month history of diplopia, decreased vision, and right upper eyelid swelling. Radiographic imaging showed a soft tissue mass in the extraconal compartment superolateral to the right eye. The patient subsequently underwent surgical debulking. Histologic examination of the tissue revealed classic cribiform adenoid cystic carcinoma and a sarcomatous component consisting of malignant spindle cells and fusiform cells arranged in whorls. Dedifferentiation is a well-established phenomenon in salivary gland tumors that is associated with aggressive behavior and poor prognosis; however, the exact nature of such dedifferentiated neoplasms remains unclear.

Tenon recession: a novel adjunct to improve outcome in the treatment of large-angle strabismus in thyroid eye disease.

PURPOSE: Treatment of large-angle strabismus in thyroid eye disease has historically suffered from low success rates. The authors report a novel technique that adds Tenon recession without conjunctival recession to standard extraocular muscle surgery. METHODS: Twenty-six patients with thyroid eye disease-associated strabismus with preoperative deviations of ≥ 25 prism diopters in horizontal or vertical deviations underwent strabismus surgery. The amount of recession for a given muscle was determined by a combined analysis of the preoperative versions, deviation in primary gaze and in gaze opposite the restricted muscle, and intraoperative forced duction testing. Before conjunctival closure, the underlying Tenon layer and associated orbital tissues were recessed and allowed to retract posteriorally. The overlying conjunctiva was subsequently reapproximated to its anatomic position without tension. RESULTS: The average preoperative measurements for horizontal and vertical deviations were 39.2 ± 13.4 and 45.0 ± 18.9 prism diopters, respectively. Average postoperative measurements for horizontal and vertical deviations were 3.2 ± 6.0 and 11.1 ± 11.9 prism diopters, respectively. Overall, 22 of 26 patients (84.6%) were within 10 prism diopters of intended correction postoperatively and achieved binocular fusion with or without the use of prisms for both distance and near vision. Four had residual deviations that required reoperation, all of which successfully produced binocular vision without the use of prisms. CONCLUSIONS: In the authors' experience, Tenon recession improves outcomes in surgery for large-angle strabismus in thyroid eye disease.