Comparative Clinical and Histomorphological Evaluation of the Efficacy of the Injectable Belotero® Soft (CPM-HA S) and Radiesse® (CaHa) Combination

Abstract

Background: No single technology, filler, or neuromodulator can achieve all the results desired in treating the aging face. Combined aesthetic interventions have widespread application in clinical practice, but results are infrequently reported at scientific meetings and in the medical literature, as the area is difficult to study. Expert consensus supports a combination approach using multiple modalities in specific sequence for the safe and effective treatment of the aging face. Belotero ® Soft (CPM-HA S, 20 mg/mL) and Radiesse ® (CaHA) being dermal fillers are Ministry of Health of the RF and FDA-approved. Their effectiveness and safety have been demonstrated in a number of studies. Methods:The study was designed as an open-label, prospective, pilot, randomized, comparative clinical study and immunohistochemical analysis in healthy female volunteers, 35-45 years of age with BMI < 21. Fourteen study subjects lived up with inclusion/exclusion criteria and were randomly assigned to experimental groups with a 1:1 who had one CPM-HA S injection all over the face and into integumentary tissues of the periauricular area (subdermal injection) at the first Visit (D01) and followed subdermal diluted CaHA (Group I) or standard CaHA (Group II) injection at the second stage (M01). The study was comprised of three visits. As a primary endpoint the clinical efficacy in terms of a lifting effect of the combined injections was assessed by independent experts using the Merz Aesthetics Scales™. The secondary efficacy endpoints included the Global Aesthetic Improvement Scale (GAIS) completed both the study subjects and the investigators, skin elasticity testing by means of cutometry and the histomorphological evaluation based on the type I collagen, the type III collagen and the elastic fibers' analysis using immunohistochemistry test (IHC) in terms of the compatibility of the combination of CPM-HA S and CaHA was assessed at Stage 2 (M01) and at Stage 3 (M06) compared to the baseline data. Mild staining corresponded to marker expression of 2 points, moderate -4 points, and high -6 points.Results: Patient satisfaction evaluation based on the GAIS Scale showed no difference between study subject's score and practitioner's score due to a small sample size and a short follow-up period. A comparative analysis of histology and immunohistochemistry of samples following the combined injection of CPM-HA S and CaHA reconstituted with normal saline as well as standard showed that these interventions had a relatively greater remodeling effect on the dermis. This conclusion is confirmed by intense type I