A split-face comparative performance evaluation of injectable hyaluronic acid-based preparations HCC and CPM-HA20G in healthy females.

INTRODUCTION: Skin revitalizers are used for skin quality improvement purposes. Hyaluronan hybrid cooperative complexes (HCC, Profhilo®, IBSA Pharmaceuticals) are an anti-aging treatment with a large amount of pure hyaluronic acid (HA) based on stable, cooperative, and hybrid complexes. Cohesive polydensified matrix Hyaluronic Acid (CPM-HA20, Belotero Revive®, Merz Pharmaceuticals GmbH) is a slightly cross-linked HA (20 mg/ml) with glycerol (17.5 mg/ml). AIMS: To evaluate the performance of HCC and CPM-HA20G for skin quality improvement in healthy female subjects. METHODS: This was a split-face, single-blinded study that enrolled 24 healthy female subjects. Injections were given on three separate occasions. HCC was injected on the right cheek, while CPM-HA20G was injected on the left cheek. A battery of skin property measurements was used to evaluate the skin. Skin properties and overall satisfaction were analyzed using mixed models with the values at baseline, at week 1, week 8, and week 14 as an outcome and a random effect of subject and fixed effects of treatment, visit, and the treatment by visit interaction. RESULTS: Both products showed evidence of effect relative to baseline on surface hydration (AU), elasticity (N/m) TEWL (g/m2 h), and melanin (AU). CPM-HA20G also showed significant evidence of effect relative to baseline on water content (%), and HCC on pore count (n) and hemoglobin (AU). Satisfaction reported by the subjects themselves showed positive trends of satisfaction over time for multiple skin properties. There were no significant differences between the tested products in the observed skin characteristics over time. CONCLUSION: These devices are effective and safe treatments for skin quality improvement, especially moisturization, with high patient satisfaction and generally mild and transient side effects.

Evaluating the Effect of Incobotulinumtoxin A for Glabellar, Forehead, and Crow's Feet Lines Using A High Dilution.

BACKGROUND: As aesthetic preferences have evolved and patients wish their muscles to be relaxed, but not frozen, a higher dilution of incobotulinumtoxinA (INCO) has allowed for increased spread using fewer units, yet no studies to date have investigated the efficacy, longevity, and safety of hyperdiluted INCO. OBJECTIVE: We evaluated the effect of incobotulinumtoxinA (INCO) in glabellar, forehead, and lateral periorbital lines using a high dilution. METHODS: Subjects with moderate-to-severe upper facial lines at rest according to the Merz Aesthetics Scales™ (Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) received 15U of INCO to the glabellar (n=4 injection sites), 10U to the rest of the forehead (n=10 injection sites), and 5U to the lateral periorbital lines (n=3 injection sites/eye). Primary outcomes were physician- and subject-rated improvement at one month using the Global Aesthetic Improvement Scale (GAIS) and changes in line severity using the Merz Aesthetics Scales™. RESULTS: The study included 15 women aged 35 to 65 years. At one month, physician GAIS scores indicated 91.2% of subjects were very much improved and 8.8% were much improved; 91.5%, 78.0%, and 57.6% of participants remained at least improved at four, five, and six months, respectively. Subject GAIS scores at one month were in agreement with physician scores. At one month, an improvement of at least one point in Merz Aesthetics Scales™ scores in glabellar, forehead, and lateral periorbital lines was reported in 88.9%, 98.3%, and 94.8% of participants, respectively. Subject satisfaction was high throughout the study. No treatment-related adverse events were observed. CONCLUSION: Hyperdilute INCO was effective at improving overall appearance and reducing line severity in individuals with moderate-to-severe upper facial lines. Patient satisfaction was maintained up to six months and treatment was well tolerated.

Delayed Inflammatory Reactions to Hyaluronic Acid Fillers: A Literature Review and Proposed Treatment Algorithm.

BACKGROUND AND OBJECTIVES: There is a wide diversity of opinions regarding the management of delayed inflammatory reactions (DIRs) secondary to hyaluronic acid (HA)-based fillers. The plethora of approaches has led the authors to conduct a review regarding management and treatment of DIRs as well as establish therapeutic guidelines for this purpose. MATERIALS AND METHODS: A review of the literature was performed through databases such as PubMed using keywords including HA-fillers and complications, delayed HA filler sequelae and therapy, soft tissue and dermal filler reactions and management. Additionally, a survey comprised of questions regarding the management and treatment of DIRs was sent to 18 physicians highly experienced with soft-tissue filler injections in 10 countries. Their answers and recommendations were analyzed and debated amongst these panelists. RESULTS: Sixteen panelists favored antibiotic therapy as first-line treatment for DIRs, specifically dual antibiotic therapy consisting of a fluoroquinolone along with a tetracycline or macrolide for a period of 3-6 weeks. The majority refrained from the use of intralesional (IL) or systemic steroids except in the case of disfiguring or recalcitrant reactions. IL hyaluronidase was recommended by 13 panelists; however, some preferred a watchful waiting approach for a period of 48 hours to 2 weeks prior to IL hyaluronidase, and in cases where antibiotics did not lead to improvement. CONCLUSION: A consensus was reached and summarized to propose a clear, easy-to-follow, stepwise algorithm for the treatment of DIRs.

Use of calcium hydroxylapatite in the upper third of the face: Retrospective analysis of techniques, dilutions and adverse events.

Calcium hydroxylapatite (CaHA) is a commonly used soft tissue filler for aesthetic facial improvement, in particular for the lower and mid-face. The golden standard for upper facial filler indications is hyaluronic acid (HA) injection. In this report we investigate the safety, efficacy and complication rates after injections of CaHA to the upper third of the face using a variety of different techniques. This was a retrospective analysis performed on patients who had received CaHA in 2016 and 2017 at various dilutions in the upper third of the face (frontal area, eyebrows and temporal hollows) using a number of injection techniques and both blunt-tipped cannulas as well as sharp needles. Records of adverse events and side effects were studied. Seventy patients had been injected with CaHA in the upper third of the face. There were 36 treatments to the frontal area, most with a cannula in the subgaleal space with standard dilution of CaHA (16.7% lidocaine containing epinephrine). There were 13 treatments to the brow, mostly with a cannula and multilevel technique, and 66 treatments to the temporal hollows, mostly with a cannula in the interfascial space with standard CaHA dilution. No serious complications were recorded. CaHA was effective and well-tolerated for a range of upper-face indications. More (prospective) research is required to further determine the value of CaHA treatments in these areas.

Complication Management following Rejuvenation Procedures with Hyaluronic Acid Fillers-an Algorithm-based Approach.

BACKGROUND: Hyaluronic acid is an ideal facial filler, however, although established as both safe and effective, complications do occur. Treatment recommendations that combine both expert opinions and clinical trial data are currently lacking, partly due to difficulties with diagnoses, nonspecific diagnostic investigations, and certain disorders presenting with similar symptoms, thereby confounding diagnosis and treatment. METHODS: The purpose of this article was to provide the aesthetic clinician with practical recommendations regarding complication diagnosis arising as a consequence of hyaluronic acid filler rejuvenation treatment. It also provides recommendations for their management using step-wise treatment algorithms that are based on published expert opinions, as well as the author's clinical experience. RESULTS: Algorithms are provided for the most common categories of complication associated with hyaluronic acid filler treatment, that is, skin discoloration, edema, nodules, infection, and vascular compromise. CONCLUSIONS: These guidelines are not intended to be complete or exhaustive but may prove informative for aesthetic clinicians who are responsible for treating patients with hyaluronic acid fillers. It may help to guide them on recognizing potential complications and it provides clear guidance on optimum treatment pathways.

Cannula Versus Sharp Needle for Placement of Soft Tissue Fillers: An Observational Cadaver Study.

BACKGROUND: Soft-tissue fillers have become important products for facial rejuvenation. Deep fat compartments and facial bones lose volume during the natural aging process. For the most natural-looking results, deep volumetric injections at strategic sites are therefore preferred. Supraperiosteal placement is performed with a sharp needle or a non-traumatic cannula. OBJECTIVES: The primary objective was to determine whether there is a difference in precision between supraperiosteal placement with a sharp needle compared with a non-traumatic cannula in cadaver specimens. A secondary objective was to analyze the safety profiles of both injection techniques. METHODS: Cadaver heads were injected with dye material and soft-tissue fillers at multiple aesthetic facial sites on the supraperiosteum and subsequently dissected for observation of dye and filler placement. RESULTS: The non-traumatic cannula technique resulted in product being confined to the deep anatomic layers. In contrast, with the sharp needle technique, material was placed in multiple anatomic layers, from the periosteum to more superficial skin layers. For both techniques results were consistent for all facial sites. CONCLUSIONS: Although direct extrapolation from cadavers to the in vivo situation cannot be made, cannulae showed more precision in placement of product. With the sharp needle, the material was injected on the periosteum, and then migrated in a retrograde direction along the trajectory of the needle path, ending up in multiple anatomic layers. The sharp needle technique also showed a higher complication risk with intra-arterial injection occurring, even though the needle tip was positioned on the periosteum and the product was injected with the needle in constant contact with the periosteum.