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Rockville, MD, United States

Emer J.,University of California at San Francisco | Sundaram H.,Sundaram Dermatology
Journal of Drugs in Dermatology | Year: 2013

BACKGROUND: Calcium hydroxylapatite filler (CaHA; Radiesse) is a synthetic, non-animal derived product composed of minerals that occur naturally in bone and teeth. Following its development in the US, initial approval by the US FDA for non-aesthetic indications and CE marking in Europe, it was used off FDA-labeling for aesthetic purposes. Its use has grown further since its FDA approval in 2006 for long-lasting correction of moderate to severe wrinkles and folds. It is a popular filler for volume restoration to the face, and also to nonfacial areas such as the dorsum of the hands. METHODS: The first article of this two-part series provides an evidence-based review of study data pertaining to the mechanism of action and biocompatibility of CaHA filler, and its safety, efficacy and tolerability when used for aesthetic purposes. The review includes data from a number of prospective, controlled comparative studies, from several retrospective studies, and from a meta-analysis of reported complications from alloplastic filler procedures over a 20-year period. The study methodology and number of study subjects are sufficiently robust to provide a high Evidence Level for much of the data. RESULTS: CaHA has good safety, efficacy and tolerability profiles that are comparable to those of hyaluronic acid (HA) fillers. It provides an initial, immediate volume replacement for up to 12 months followed by longer term correction due to biostimulation, resulting in collagenesis. Evidence Level II studies show longevity of 30 months or more after nasolabial fold implantation. Other studies demonstrate the appropriateness of CaHA filler for volume restoration to areas including the mid face, lower face and hands. CaHA is classified as an adjustable filler, whereas HA is fully reversible by hyaluronidase digestion. For this reason, and also because of CaHA's high viscosity and elasticity, evidence-based and experiential consensus suggests its avoidance in highly mobile areas (e.g. lips) or in anatomically unforgiving areas (e.g. the periocular region), where there may be increased incidence of nodules. CONCLUSION: CaHA filler is safe, efficacious and well-tolerated when used appropriately. It is increasingly recognized that many patients require pan-facial volume restoration, and that many can benefit from combined treatments. Therefore, CaHA and HA fillers may be considered complementary rather than competitive to each other. The second article of this series offers a discussion of product characteristics, scientific principles and injection techniques to optimize treatment with CaHA filler, including special considerations for avoidance and management of complications. Copyright © 2013 Journal of Drugs in Dermatology.

Fabi S.G.,Goldman | Sundaram H.,Sundaram Dermatology | Guiha I.,Goldman | Goldman M.P.,Goldman
Journal of Drugs in Dermatology | Year: 2013

Background: Lateral canthal rhytides partly result from repetitive muscular actions of the orbicularis oculi. Objective: To determine the efficacy of one versus three injection sites of AbobotulinumtoxinA (ABO) in the treatment of lateral canthal rhytides. Methods: This was a two-center, evaluator-masked, 120 day study in which 40 patients with moderate to severe hyperdynamic lateral canthal rhytides at maximal contracture were randomized to receive one injection of 36 Units of ABO into the middle of the lateral orbital rhytides on one side, with the contralateral side treated with the same total dose of ABO, divided into three intradermal injections of 12 Units each, along the lateral canthal area. A blinded evaluator assessed lateral orbital rhytides at rest and maximal contraction at baseline, 7, 42, 90, and 120 days post treatment. Standardized digital photography and subject selfassessment were performed at each visit. Results: No statistically significant difference was seen at any visit between sides treated with one injection and those treated with three injections in any evaluation category. There was no difference in adverse events between the two sides. Conclusion: Sites treated with three injections of ABO showed no statistically significant difference from those treated with one injection. Copyright © 2013 Journal of Drugs in Dermatology.

Sundaram H.,Sundaram Dermatology | Flynn T.,Cary Skin Center | Cassuto D.,University Hospital Policlinico of Modena | Lorenc Z.P.,Lorenc Aesthetic Plastic Surgery Center
Journal of Drugs in Dermatology | Year: 2012

In the years since the U.S. FDA approval in 2003 of the first hyaluronic acid (HA) filler, a number of other HA products have become available for use in the U.S., in addition to products composed of calcium hydroxylapatite (CaHA), poly-L lactic acid (PLLA) and polymethyl methacrylate (PMMA). This roundtable discussion between two US-based dermatologists, a European plastic surgeon, and a US-based plastic surgeon provides an overview of commonly used alloplastic filler products and examines how new strategies for soft tissue augmentation are developing as filler options continue to expand. Copyright © 2012 Journal of Drugs in Dermatology.

Fabi S.,Goldman | Fabi S.,University of California at San Diego | Sundaram H.,Sundaram Dermatology
Facial Plastic Surgery | Year: 2014

Growth factors and cytokines (referred to collectively hereafter as GFs) control cell growth, proliferation, and differentiation via a network of inter and intracellular signaling pathways. There are striking parallels between the pathways involved in skin wound healing and those implicated in photoaging of the skin. In recent years, topical and injectable GFs have emerged as an intriguing therapeutic modality that can be harnessed for aesthetic and medical purposes. This article provides a review of available evidence for the role in skin regeneration of topical GFs, and of injectable GFs contained in autologous platelet-rich plasma (PRP). It presents data from recent studies of GFs, offers a discussion of their potential to serve as antiaging actives, and includes safety considerations. As studies of injectable GFs typically assume preexisting familiarity with PRP protocols and the theory behind them, explanatory notes are provided. An assessment is provided of the evidence gaps that exist currently between experimental observations regarding GFs and their proven clinical benefits. Data of evidence levels II and III support the use for skin rejuvenation of topical GFs derived from sources including secretions or lysate of human dermal fibroblasts, and secretions of the snail Cryptomphalus aspersa. GFs with associated stem cell proteins, secreted by human dermal fibroblasts under hypoxic stress, can accelerate skin healing after laser resurfacing. In vitro and animal studies, small case series of PRP-treated patients and one prospective clinical study of its variant, platelet-rich fibrin matrix (PRFM), suggest the value of injectable GFs for skin rejuvenation. However, data of higher power are required to expand this proof of concept into an evidence-based paradigm. The clinical applications of topical and injectable GFs are promising, and remain to be fully defined. With continued study, data of higher evidence level can be accrued and formulations can be developed that offer optimal clinical efficacy, safety, tolerability, and stability. Better understanding of the mechanism of action of GFs can potentially advance our general understanding of dermal signaling pathways, and hence of hyaluronic acid and other alloplastic fillers; and allow the development of protocols for synergistic combination of GFs with other skin rejuvenation modalities. © 2014 by Thieme Medical Publishers, Inc.

Sundaram H.,Sundaram Dermatology | Pozner J.,Cleveland Clinic
Journal of Drugs in Dermatology | Year: 2012

As blunt injection microcannulas increase in popularity, clinicians may find it of value to have a systematic review of their current uses. This consensus document is derived from a roundtable discussion between a multi-specialty faculty comprising two U.S.-based dermatologists, one U.S.-based plastic surgeon, and one European cosmetic surgeon, all of whom were early adopters of blunt microcannulas for alloplastic fillers. The purpose of this consensus document is to provide an overview of the utility and clinical applications of blunt microcannulas, guidelines for their safe and efficacious use, and recommendations for the further evidence that needs to be accrued to substantiate the claims that have been made in regard to their superior safety profile and other benefits. Copyright © 2012 Journal of Drugs in Dermatology.

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