Calcium Hydroxylapatite for Augmentation of Face and Hands: A Retrospective Analysis in Italian Subjects
September 2015 | Volume 14 | Issue 9 | Original Article | 948 | Copyright © 2015
Gabriele F. Muti MD,a Giorgio Astolfi MD,b Massimo Renzi MD,c and Pier P. Rovatti MDd
aPlastic Surgery Department, Istituto Dermatologico Europeo, Milano, Italy
bAesthetic Medicine, Centro di Dermatologia Integrata e Medicina Preventiva (CDM) Institute, Milan, Italy
cPrivate Practice, City Med Poliambultorio, Genova, Italy
dPrivate Practice, Pierpaolorovatti Medical Office, Verona, Italy
To assess the use and safety of calcium hydroxylapatite for volume restoration of the face and hands in clinical practice, subjects from four Italian aesthetic clinics who had received calcium hydroxylapatite augmentation treatment between January 2012 and December 2013 were recruited. Records were retrospectively reviewed for demographic characteristics, number of treatments, area treated, injection depth and volume, method of administration, and adverse events. A total of 1,783 treatments were administered to 800 subjects (female: 93.5%; mean age: 49.6 years). Overall, 620 (77.5%) subjects were treated over two sessions for a particular indication, and 243 (30.3%) treated over three sessions. The most frequently treated areas were the zygomatic area (men: 30.2%; women: 30.6% of all treatments), malar area (24.5% and 24.3%), and marionette lines (18.9% and 11.6%). A cannula was used for most treatments (86.7%). Injection volume ranged from 0.4 mL to 1.5 mL. Injection-site swelling and bruising occurred with 18.2% and 11.3% of treatments, respectively. Most cases resolved within one week and two weeks, respectively. No serious/unexpected adverse events occurred. In clinical practice, calcium hydroxylapatite is a versatile, well-tolerated treatment for filling folds and volume restoration of the face and hands.
J Drugs Dermatol. 2015;14(9):948-954.
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Dermal fillers are increasingly being used as a minimally invasive therapy for the correction of facial volume loss associated with aging.1 A calcium hydroxylapatite filler (Radiesse®; Merz Pharmaceuticals GmbH, Frankfurt, Germany) has been shown to stimulate neocollagenesis2-4 and is widely used for the treatment of nasolabial folds and volume restoration of the face.5-9 It has also demonstrated efficacy, with an established safety profile, for the rejuvenation of the dorsum of the hand.10-15
In 2006, calcium hydroxylapatite received a CE mark in Europe for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds, and for plastic and reconstructive surgery, including deep and subdermal soft-tissue augmentation of the facial area. In the same year, it was also approved by the FDA for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds and for the restoration and correction of the signs of facial lipoatrophy in patients with HIV.16 In 2015, the FDA approved calcium hydroxylapatite for hand augmentation to correct volume loss in the dorsum of the hands.17 No serious safety concerns with calcium hydroxylapatite have been reported after over a decade on the market.18-20
When administering dermal fillers, numerous factors need to be considered that may affect the aesthetic outcome or the adverse events experienced. These include the area to be treated, the depth of the injection, the goal of the procedure, product particle size, degree of cross-linking, injection volume, needle or cannula size, and combination with local anesthetics.6,21-25 The aim of this study was to draw on the considerable experience of the investigators to provide data on the use and safety of calcium hydroxylapatite in clinical practice in Italy for volume restoration of the face and the hands.
MATERIALS AND METHODS
This was a retrospective review of medical records from eligible Italian subjects who received treatment with calcium hydroxylapatite to restore the volume of the face and/or hands. Written informed consent was obtained from each subject at the time of the original treatment, and ethical approval for this analysis was gained from the ethical committee of the Istituto Dermatologico Europeo, Milan, Italy.
Records of subjects who sought treatment at four participating Italian aesthetic clinics (two clinics in Milan, one clinic in Verona and one clinic in Genoa) between January 2012 and December 2013 were suitable for inclusion if, after consultation with the practitioner, the subject had received treatment with calcium hydroxylapatite. Records of patients who had received laser or hyaluronic acid treatment in the 6 months prior to study, were