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Treatment of facial lipoatrophy, morphological asymmetry, or debilitating scars with the hyaluronic acid dermal filler Princess® FILLER.

ABSTRACT: Purpose:The aim of this study was to evaluate the effectiveness and safety of hyaluronic acid (HA) dermal filler when used in the face for medical reconstructive purposes. Patients and methods:Adult patients with moderately severe facial lipoatrophy (FLA), morphological asymmetry (MA) of the face, or debilitating scars (DS) on the face were included in a prospective, noncomparative, multicenter, postmarket clinical follow-up study. All patients were treated with an HA filler (Princess® FILLER), which was injected intradermally on study Day 1, with optional touch-up 2 weeks later. The effectiveness of the treatment was evaluated at Weeks 4 and 24, using a six-grade scale ranging from "excellent" to "worsening". The assessments were conducted by both the investigator and the patient and, at Week 4, by the independent photography reviewer as well. Adverse events were collected at each visit. Results:Fifty-three patients were included in the study (FLA 23, MA 17, and DS 13), and 46 patients completed a 6-month follow-up (FLA 20, MA 15, and DS 11). At Week 4 (primary endpoint), the overall treatment success rate was 100% (FLA), 100% (MA), and 94% (DS), based on assessments made by the investigator, patients, and the independent reviewer, respectively. In most patients (~95%), the effect was sustained over 6 months. Treatment-related adverse events were reported in five patients (9%) and included injection site hematoma, injection site pain, and headache. Conclusion:Dermal filling with HA gel is a viable treatment option for the correction of various deformities of the face resulting from FLA, MA, or DS.

SUBMITTER: Kopera D

PROVIDER: S-EPMC6267730 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Treatment of facial lipoatrophy, morphological asymmetry, or debilitating scars with the hyaluronic acid dermal filler Princess<sup>®</sup> FILLER.

Kopera Daisy D Ivezic-Schoenfeld Zrinka Z Federspiel Ira G IG Grablowitz Doris D Gehl Benjamin B Prinz Martin M

Clinical, cosmetic and investigational dermatology 20181127

<h4>Purpose</h4>The aim of this study was to evaluate the effectiveness and safety of hyaluronic acid (HA) dermal filler when used in the face for medical reconstructive purposes.<h4>Patients and methods</h4>Adult patients with moderately severe facial lipoatrophy (FLA), morphological asymmetry (MA) of the face, or debilitating scars (DS) on the face were included in a prospective, noncomparative, multicenter, postmarket clinical follow-up study. All patients were treated with an HA filler (Prin ...[more]

PMID: 30568476

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Project description:BackgroundThe ongoing expansion of the cosmetic armamentarium of facial rejuvenation fails to uncover the inherent risks of cosmetic interventions. Informed consent to all risks of cosmetic filler injections and potential sequelae, including ocular and neurological complications, should be carefully ensured. We present two cases of complications following facial hyaluronic acid filler injections.Case presentationsCase 1: A 43-year-old woman presented with monocular vision loss of the left eye, associated ptosis, ophthalmoplegia, periocular pain and nausea, cutaneous changes of the glabella region and forehead, and sensory impairment in the left maxillary branch dermatome (V2) after receiving a hyaluronic acid (HA) filler injection into the left glabellar area. On ophthalmological examination, an ophthalmic artery occlusion (OAO) was diagnosed upon identification of a "cherry-red spot". Magnetic resonance imaging (MRI) revealed a left ischemic optic neuropathy. Supportive therapy and hyaluronidase injections were initiated. A follow-up MRI of the head performed two months after presentation corresponded to stable MRI findings. The patient had irreversible and complete vision loss of the left eye, however, the ptosis resolved. Case 2: A 29-year-old woman was admitted to hospital a few hours after a rhinoplasty and cheek augmentation with hyaluronic acid, presenting with acute monocular vision loss in the right eye, retrobulbar pain, fatigue and vomiting. In addition, the patient presented a harbinger of impending skin necrosis and a complete oculomotor nerve palsy on the right side, choroidal ischemia and vision impairment. Supportive treatment and hyaluronidase injections into the ischemic tissue were initiated. A small scar at the tip of the nose, vision impairment and an irregular pupillary margin on the right side persisted at follow-up.ConclusionThese two case reports and the literature review emphasize the pathophysiological mechanisms leading to potentially devastating complications. In order to reduce the risk of vision loss secondary to cosmetic filler injections, practitioners should possess a thorough knowledge of anatomy and preventive strategies.

Project description:Introduction: The lips and the mouth play an indispensable role in vocalization, mastication and face aesthetics. Various noxious factors may alter and destruct the original structure, and appearance of the lips and the anatomical area surrounding the mouth. The application of hyaluronic acid (HA) may serve as a safe method for lip regeneration. Although a number of studies exist for HA effectiveness and safety, its beneficial effect is not well-established. Aim: The present meta-analysis and systematic review was performed to investigate the effectiveness of HA on lip augmentation. We also investigated the types and nature of adverse effects (AEs) of HA application. Methods: We reported our meta-analysis in accordance with the PRISMA Statement. PROSPERO protocol registration: CRD42018102899. We performed the systematic literature search in CENTRAL, Embase, and MEDLINE. Randomized controlled trials, cohort studies, case series and case reports were included. The untransformed proportion (random-effects, DerSimonian-Laird method) of responder rate to HA injection was calculated. For treatment related AEs descriptive statistics were used. Results: The systematic literature search yielded 32 eligible records for descriptive statistics and 10 records for quantitative synthesis. The results indicated that the overall estimate of responders (percentage of subjects with increased lip fullness by one point or higher) was 91% (ES = 0.91, 95% CI:0.85-0.96) 2 months after injection. The rate of responders was 74% (ES = 0.74, 95% CI:0.66-0.82) and 46% (ES = 0.46, 95% CI:0.28-0.65) after 6 and 12 months, respectively. We included 1,496 participants for estimating the event rates of AEs. The most frequent treatment-related AEs were tenderness (88.8%), injection site swelling (74.3%) and bruising (39.5%). Rare AEs included foreign body granulomas (0.6%), herpes labialis (0.6%) and angioedema (0.3%). Conclusion: Our meta-analysis revealed that lip augmentation with injectable HA is an efficient method for increasing lip fullness for at least up to 6 months after augmentation. Moreover, we found that most AEs of HA treatment were mild or moderate, but a small number of serious adverse effects were also found. In conclusion, further well-designed RCTs are still needed to make the presently available evidence stronger.

Dataset Information

Treatment of facial lipoatrophy, morphological asymmetry, or debilitating scars with the hyaluronic acid dermal filler Princess® FILLER.

Publications

Treatment of facial lipoatrophy, morphological asymmetry, or debilitating scars with the hyaluronic acid dermal filler Princess<sup>®</sup> FILLER.

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