Post marketing study of safety and efficacy of Crystalys, a calcium hydroxyapatite based filler for facial soft tissue augmentation

Tsvi Segal, MD; Ana Schwartz, MD; Konstantin Konfino, MD, PhD

Objective: In this post marketing study our primary objective was to assess the safety of Crystalys, a new calcium hydroxyapatite based filler, in subjects who received sub-dermal or deep-dermal injections for facial soft tissue augmentation. The secondary objective was to evaluate the performance of Crystalys within six months of injection.

Methods: Crystalys was injected to 173 patients, age ranging from 27–72 years, with a variety of facial aesthetic conditions, most common being pronounced nasolabial folds. On average, patients were injected with 3.4 ml of Crystalys. After obtaining informed consent form, the subjects were evaluated for adverse events (AEs) and efficacy using three different performance methods.

In this post marketing study, high safety and performance level of Crystalys for facial soft tissue augmentation was observed. The study was administered to 173 patients with varying facial deficiencies and results were evaluated using different performance methods.

Results: Safety – 173 patients were evaluated for adverse events. No severe, serious or longlasting AEs were reported or recorded by patients or physicians. In addition, all events were selfresolving. All reported AEs are common when treated with all injectable fillers. The AEs reported were: Ecchymosis, Edema, Erythema and Pain. Efficacy – efficacy ratings were performed on a subset of 59 patients using the Lemperle Rating Scale (LRS) and the Global Aesthetic Improvement Scale (GAIS) validated clinical scales. In addition, a 5-point Likert scale User Satisfaction Questionnaire was filled out by 72 patients. Crystalys dermal implant demonstrated excellent efficacy results, using both the LRS and GAIS scales, and by user satisfaction ratings. All scales indicated an overall improvement in treated facial areas, coupled with markedly high patient satisfaction scores.

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Nonsurgical Rhinoplasty: a Safety of Calcium Hydroxyapatite Filler Used for Nose Sculpt

David Mor-Yosef, MD; Konstantin Konfino, MD, PhD; Roni Moscona, MD

The use of dermal fillers for a nonsurgical rhinoplasty requires a medical knowledge of nasal anatomy. The deep fatty layer is targeted as it is known as the safe plan for filler deposition.

Therefore, the filler should be injected exactly underneath the fibromuscular layer and above the perichondrium/periosteum layer in order to avoid a superficial injection or an inaccurate injection into the nose's major blood vessels and artery systems [1– –5]. The advantages of a calcium hydroxyapatite filler used for nose sculpt arise from its ability to alter the shape of the nose at the anatomic region where it was positioned [6–8]. Also, when injected directly, the filler has the ability to correct aesthetic deformities without having the patient go through a complicated rhinoplasty procedure [9,10]. Moreover, it can also be used for the correction of postrhinoplasty deformities [11].

The primary aim of the study detailed in the included article was to assess the safety of Crystalys, a calcium hydroxyapatite injectable filler, used in nonsurgical rhinoplasty as well as its performance within a six-month period. The results of the study demonstrated that Crystalys is safe for nonsurgical rhinoplasty and holds a constant high level of performance.

The dermal filler of choice used in this study was Crystalys, a calcium hydroxyapatite injectable filler (Panaxia Ltd.). Crystalys is a sterilized, apyrogenic, long lasting and non-permanent injectable facial implant. It is a homogenous, semi-solid implant, intended for sub- and deep-dermal use, it is provided in a 1.25 mL pre-filled graduated, glass syringe. The filler is based on synthetic calcium hydroxyapatite, the major material of teeth and bones [12]. It consists of microspheres of calcium hydroxyapatite formulated to a concentration of 55.7% CaHA, suspended in an aqueous gel carrier of glycerol and sodium carboxymethylcellulose. When injected, the CaHA microspheres form a framework for ingrowth by fibroblasts, which steadily substitute the carrier vehicle.

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Non-Surgical Rhinoplasty: Procedure and Advantages

Aesthetic Dermatology, Rhinoplasty

In the last 6 years, I have gained a vast experience in non-surgical rhinoplasty or "nose sculpturing". There are several indications in the nasal area that can be treated. We can treat depressions in the bridge of the nose, fill the tip of the nose, lift or adjust its angle, correct nose projections and others. The treatment will always include a thorough examination of the patient, in order to assess the suitability for the treatment, patient preparation, and area disinfection. The injection is to the supra-periost plane, in a vertical angle. One can use a needle or a cannula, depending on the nose features and the needed correction. After the

Dr. David Mor-Yosef demonstrates his step by step procedure for performing nonsurgical rhinoplasties using Crystalys dermal filler. He explains the advantages of Crystalys, a calcium hydroxyapatite-based filler, for nose sculpting and general facial contouring treatments.

injection a manual sculpturing is required to achieve optimal results. After treatment, the mild bleeding from the treatment should be stopped with a gentle pressure. Ice should be applied, to prevent or reduce the generation of swelling and hematoma formation.

Luminera's Crystalys filler is very well suited for treatment of volume loss and facial contouring. Facial features that need emphasizing, such as cheek bones, chin or jaw line, can be easily and effectively treated with Crystalys. In addition, as we age, the bones lose their mass, and the 3D structure of the face is flattened. For the treatment of such flattening, Crystalys is the most suited product. Crystalys treatment will generate or restore a full face look, give long lasting results, and a natural appearance.

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Calcium Hydroxyapatite Based Filler for Facial Soft Tissue Augmentation

Aesthetic Dermatology, Aesthetic Medicine Dr. Konstantin Konfino, MD, PhD, is a Dermatologist with a PhD in skin virology and dermatology. He owns a successful private clinic in Tel Aviv and works for the Maccabi Health Care Services in Tel Aviv, Israel. We spoke to Dr. Konfino about a new calcium hydroxyapatite based filler (Crystalys).

Dr. Konstantin Konfino, MD, PhD, is a Dermatologist with a PhD in skin virology and dermatology. He owns a successful private clinic in Tel Aviv and works for the Maccabi Health Care Services in Tel Aviv, Israel.

We spoke to Dr. Konfino about a new calcium hydroxyapatite based filler (Crystalys) which is used in sub-dermal or deep-dermal injections for facial soft tissue augmentation.

Dr. Konstantin Konfino details his experience with Luminera’s calcium hydroxyapatite-based filler, Crystalys. He explains the advantages of the Crystalys over hyaluronic acid fillers and the superior results he experiences in his clinic with the product. Furthermore, clinical data collected from 218 patients proves Crystalys’s safety profile and superior patient experience.

Data collected from 218 patients demonstrated an excellent safety profile and superb performance results for Crystalys.

A postmarketing study of 218 patients assessed safety and performance parameters associated with Crystalys treatment [1]. Medical files were retrospectively analyzed and “post-treatment” photos were obtained and scored by a trained practitioner by means of validated clinical sales [Lemperle Rating Scale (LRS) and The Global Aesthetic Improvement Scale (GAIS)]. Patients also filled a satisfaction questionnaire. The results are shown in Fig. 2 and 3.

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