Journal of Cutaneous and Aesthetic Surgery
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ORIGINAL ARTICLE
Year : 2015  |  Volume : 8  |  Issue : 3  |  Page : 147-152

A prospective, comparative, evaluator-blind clinical study investigating efficacy and safety of two injection techniques with Radiesse ® for the correction of skin changes in aging hands


Vallex M Clinic of Preventive Medicine; Department of Skin and Venereal Diseases, Postgraduate Medical Institute, Moscow National University of Food Production, Moscow, Russia

Correspondence Address:
Elena I Gubanova
Department of Skin and Venereal Diseases, Postgraduate Medical Institute, Moscow National University of Food Production, 11, Volokolamskoe Shosse, Moscow - 125080, Russia
Russia
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Source of Support: This study was initiated by physicians at Vallex M Clinic of Preventive Medicine. The test product (Radiesse®) was supplied by Merz Pharmaceuticals GmbH for use in the study., Conflict of Interest: None


DOI: 10.4103/0974-2077.167271

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Background: Dermal fillers are used to correct age-related changes in hands. Aims: Assess efficacy and safety of two injection techniques to treat age-related changes in the hands using calcium hydroxylapatite filler, Radiesse ® . Settings and Design: This was a prospective, comparative, evaluator-blind, single-center study. Materials and Methods: Radiesse ® (0.8 mL/0.2 mL 2% lidocaine) was injected subdermally on Day (D)01, using a needle multipoint technique in one hand (N) and a fan-like cannula technique in the other (C). Assessments were made pre-injection, on D14, Month (M)02, M03 and M05 using the Merz Aesthetics Hand Grading Scale (MAS) and Global Aesthetic Improvement Scale (GAIS). Participants completed questionnaires on satisfaction, pain and adverse events (AEs). Statistical Analysis Used: Data distribution was tested with the Shapiro-Wilk and Levene's tests. The Wilcoxon signed-rank and Chi-square tests were employed to evaluate quantitative and qualitative data, respectively. Results: All 10 participants completed the study, four opted for a M03 touch-up (0.8 mL Radiesse ® ). Evaluator-assessed mean GAIS scores were between 2 (significant improvement but not complete correction) and 3 (optimal cosmetic result) at each time point. The MAS score improved from D01 to M05 (N: 2.60 to 1.40; C: 2.20 to 1.30). Following treatment, participants reported skin was softer, more elastic, more youthful and less wrinkled. Other than less noticeable veins and tendons on the C hand, no differences in participant satisfaction were noted. All AEs were mild, with no serious AEs reported. Conclusions: Both injection techniques (needle and cannula) demonstrated equivalent clinical efficacy with a comparable safety profile for the correction of age-related changes in hands with Radiesse ® .


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