A Prospective, Split-Face, Randomized, Comparative Study of Safety and 12-Month Longevity of Three Formulations of Hyaluronic Acid Dermal Filler for Treatment of Nasolabial Folds

Prager, Welf; Wissmueller, Esther; Havermann, Isabel; Bee, Eva K.; Howell, David J.; Zschocke, I.; Simon, Jeannette

doi:10.1111/j.1524-4725.2012.02468.x

Cited by 46 publications

(56 citation statements)

References 7 publications

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“…[29] A randomized, split-face study was conducted for 12 months to assess the efficacy and safety of three HA formulations: HA-1 (Belotero Basic/Balance), HA-2 (Restylane), and HA-3 (Juvéderm Ultra 3/Juvéderm Ultra Plus XC) in the treatment of nasolabial folds. [30] Participants were randomly assigned to one of two study groups, each with twenty participants. Each participant in group 1 received HA-1 on one side and HA-2 on the other, whereas participants in group 2 received HA-1 on one side and HA-3 on the other.…”

Section: Hyaluronic Acidmentioning

confidence: 99%

“…The mean pre-treatment and post-treatment nasolabial fold severity ratings did not show statistically significant differences between the groups. [30] HA is the most widely used filler yet has a relatively short duration of action, resulting in the need for constant maintenance with frequent injections for optimal treatment. [31] Recently, HA has been combined with radiofrequency (RF) devices to prolong the duration of action of HA, reducing the need for maintenance injections.…”

Section: Hyaluronic Acidmentioning

confidence: 99%

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Intradermal fillers for minimally invasive treatment of facial aging

Lin¹,

Shah²,

Dhinakar³

et al. 2016

PAR

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The ever-increasing interest in retaining a youthful physical appearance has facilitated the development of various minimally invasive dermatological techniques. The use of intradermal fillers can be incorporated into dermatological practices with minimal overhead costs. This strategy addresses facial volume loss and dynamic lines, which are the main features of facial aging. Moreover, intradermal fillers provide an array of flexible treatment options for a balanced and holistic result to dermatological practitioners. This paper reviews the different intradermal fillers categorized by biodegradable and non-permanent fillers including collagen based materials, hyaluronic acid and autologous fat, semi-permanent fillers including poly methyl methacrylate, poly-L-lactic acid and calcium hydroxyapatite microspheres, and permanent fillers including silicone. A discussion is provided of the commercial products made of these materials and their clinical efficacy in the treatment of facial aging. Key words:Intradermal fillers; facial aging; volumization; biodegradable and non-permanent fillers; semipermanent fillers; permanent fillers Xin Zhao is an associate professor at Xi'an Jiaotong University, China. Prior to starting this appointment, she was a postdoctoral fellow at Medical School and School of Engineering and Applied Sciences at Harvard University. Her research involves engineering the micro-and nanoscale systems for tissue regeneration and drug delivery.

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Section: Hyaluronic Acidmentioning

confidence: 99%

Section: Hyaluronic Acidmentioning

confidence: 99%

Intradermal fillers for minimally invasive treatment of facial aging

Lin¹,

Shah²,

Dhinakar³

et al. 2016

PAR

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“…Treatment related [79] Prospective study (n = 57), 12 months follow-up Short-term complications in 30 cases Treatment related [80] Prospective studies (n = 72), 12 months follow-up Short-term complications in 7 cases. In 2 cases migration and swelling was observed after 8 weeks Treatment related [81] Prospective studies (n = 709), 12 months follow-up…”

Section: Hyaluronic Acid (Cross-linked)mentioning

confidence: 99%

Clinical data on injectable tissue fillers: a review

Vries

Geertsma

2013

Expert Review of Medical Devices

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Treatment with injectable tissue fillers for aesthetic purposes is increasingly popular. In parallel with this success, questions related to the safety of these treatments and the products involved are being raised more prominently. To gain insight in the safety aspects of injectable tissue fillers, we performed a literature review to collect studies reporting clinical data of injectable tissue fillers. We found several case reports where serious complications after more than three years are described. However, there are only a limited number of well-defined prospective clinical studies available with follow-up periods longer than three years. Furthermore, causes of complications, that is, treatment or product related, are often not specified in literature. Considering the intended functional period of fillers in combination with the known occurrence of long-term complications, there is a need for well-defined prospective clinical studies. In order to be able to discriminate between product failure (a product safety issue) or application methodology (a physician expertise or training issue), better identification of observed complications and whether they are product or treatment related, is needed. For the safe use of the fillers it is important that treatment with injectable tissue fillers is performed by a trained physician, who knows the product specifications and its applications. . Moreover, it is expected that due to increase in life expectancy, the demand for anti-aging treatments, like tissue augmentation with injectable tissue fillers, will grow [2]. Their success has been attributed to the fact that treatments with injectable tissue fillers are fast and appear to be relatively easy [2]. Only a relatively 'simple' subcutaneous injection is needed. Today, various injectable tissue fillers with different characteristics are available, for example, duration of the effect, material type and intended anatomical location.Although the application of an injectable tissue filler seems to be relatively simple and safe, reports of serious adverse effects have appeared in the literature [2][3][4][5][6][7][8]. Estimates of the occurrence of severe complications after treatment with various types of injectable tissue fillers range between 1:80 and 1:50,000 patients [9,10]. Adverse side effects can be caused by incorrect injection techniques (treatment related) or by the characteristics of the products (product related) [11,12]. Short-, mid-and long-term complications can be discerned (TABLE 1) [2,13-15]. Short-term complications like pain, swelling, fever, immediate hypersensitivity reactions, occur immediately or within several days past treatment and disappear after several weeks. A more severe short-term complication is necrosis [5,16]. Necrosis occurs immediately or within a few days if blood vessels are obstructed by the filler material or if they are injured during the treatment [17]. Mid-term complications such as delayed inflammatory reactions, ulceration and granuloma reaction may occur after 2-12 months. I...

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“…Injecté, il est très sensible à la dégradation enzymatique. Il doit être stabilisé par réticulation chimique [1].…”

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“…Il entraine une perte de volume et à l'apparition de rides. Les produits de comblement injectables ont supplanté les techniques chirurgicales de rajeunissement [1]. Ils ont pour but d'éliminer les rides et les plis cutanés et de remodeler les contours faciaux.…”

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Complication après injection d’acide hyaluronique : présentation d’un cas

d’Elbée¹,

Fricain²

2013

Med Buccale Chir Buccale

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Résumé -Les produits de comblement à base d'acide hyaluronique (AH) constituent une référence dans la correction et l'augmentation de volume des tissus mous faciaux. Ils ont une longue durée d'action, sont peu immunogènes et peuvent être éliminés par injection locale de hyaluronidase. Ces avantages expliquent leur utilisation fréquente. Des complications aiguës ou chroniques, mineures ou sévères, peuvent survenir après leur injection, même réalisée par un praticien expérimenté. Le cas d'une patiente ayant souffert de complications infectieuses et inflammatoires chroniques après injection d'acide hyaluronique est rapporté. Abstract -Complication following the injection of hyaluronic acid: a case report. Hyaluronic acid (HA) fillershave become the material of choice for soft-tissue augmentation of the face. They are longer lasting, less immunogenic and can be broken down by hyaluronidase. These advantages make HA fillers the most common of the temporary fillers on the market. However, early and delayed complications, ranging from minor to severe, can occur following HA-filler injection even if administered by an experienced practictioner. The case of a patient who suffered from chronic infectious and inflammatory complications following the injection of hyaluronic acid is reported.

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A Prospective, Split-Face, Randomized, Comparative Study of Safety and 12-Month Longevity of Three Formulations of Hyaluronic Acid Dermal Filler for Treatment of Nasolabial Folds

Abstract: All three HAs provided essentially equivalent results, except for 4-week evenness results, which favored HA-1. Injection volumes of the three HAs were also similar.

Cited by 46 publications

References 7 publications

Intradermal fillers for minimally invasive treatment of facial aging

Intradermal fillers for minimally invasive treatment of facial aging

Clinical data on injectable tissue fillers: a review

Complication après injection d’acide hyaluronique : présentation d’un cas

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