Bio-Dermal Restoration With Rapidly Polymerizing Collagen: A Multicenter Clinical Study

An Update on the Clinical Efficacy and Safety of Collagen Injectables for Aesthetic and Regenerative Medicine Applications

“…In particular, as argued by Cho et al, injectable bioactive formulations should: (i) be biocompatible without toxicity or immunogenic phenomenon after degradation; (ii) have mechanical properties compliant with the targeted tissue; (iii) be able to keep drugs and cells in the injected area; (iv) have adequate permeability, pore size and interconnectivity for mass transport and cell colonization; (v) be cost-effective; (vi) be easily handled; (vii) be biodegradable, allowing replacement by the newly formed functional tissue [ 66 ]. Indeed, an ideal injectable formulation should form a natural open pore 3D scaffold that should allow cell migration, and slowly break down stimulating growth factors and cytokines to promote neocollagenesis, elastic fiber production, neovascularization, and the wound healing response/repair [ 67 ]. Thus, ideal injectables should not only provide immediate and stable results, but also recreate natural-like extracellular matrix (ECM) for bio-dermal restoration and a long-lasting effect.…”

“…Compared to other animal derived collagens, porcine collagen-based injections are said to be rather painful and may cause allergic reactions [ 17 ]. While bovine collagen is used for many purposes, porcine collagen is almost exclusively used for the treatment of diseases belonging to the musculoskeletal apparatus [ 130 , 131 , 132 , 133 , 134 , 135 , 136 , 137 , 138 , 139 , 140 , 141 , 142 , 143 , 144 , 145 , 146 ] (NCT02539030, NCT02519881, NCT02539095), followed by the integumental apparatus [ 67 , 76 , 86 , 87 , 147 , 148 , 149 , 150 , 151 , 152 ] (NCT03844529, NCT00891774, NCT00929071) and gastrointestinal apparatus [ 116 , 117 , 153 , 154 , 155 , 156 , 157 , 158 , 159 ]. Only recently porcine collagen potential has been explored for the treatment of facial nerve palsy [ 160 ] and for the treatment of COVID-19 due hyperinflammation [ 161 , 162 ] (NCT04517162).…”

“…Its decreased synthesis and replacement rate causes matrix loss and thus skin collapse and loss of elasticity, which in turn leads to the appearance of wrinkles, folds, and facial contour changes, as masterfully described by Fisher et al 2008 [ 215 ]. Due to this, several commercial collagen-based products are available and are used principally for facial contouring, such as for nasolabial folds [ 2 , 67 , 76 , 86 , 87 , 96 , 149 , 163 , 172 , 205 , 206 , 207 , 208 ], nasojugal folds [ 152 ], lip [ 2 , 77 , 95 , 148 , 169 , 172 ], cheek and temple area [ 172 ], glabellar groove [ 77 ], post-rhinoplasty dorsal irregularities [ 77 , 209 ], depressed acne scars [ 77 , 172 , 210 ], augmentation [ 96 , 172 ].…”

“…A total of 2–5 mL is injected to reach the desired effect. In particular, a volume of about 0.9–3.0 mL [ 67 , 86 , 95 , 149 , 205 , 206 , 207 , 208 ] is injected in the first session, but because of collagen’s rapid degradation, 1–3 touch-up treatments [ 67 , 87 , 96 , 149 , 206 ] of about 0.8–2.1 mL [ 67 , 149 , 206 ] are usually performed usually after 1–2 week from the first treatment [ 67 , 76 , 86 , 87 , 96 , 149 , 208 ] and more rarely after 1 [ 206 ] or 6 months [ 207 ].…”

“…An improvement of the Crows’ feet severity, Facial Volume Loss Scale (FVLS), and Wrinkle Severity Rating Scale (WSRS) of about 1 point was registered almost always after 6–8 months [ 86 , 163 ]. Accordingly, the improvement of the Global Aesthetic Improvement Scale (GAIS), Merz Aesthetic Scale (MAS) after 12 weeks of at least 1 point was registered in another study [ 67 ]. The maximum WSRS improvement of about 0.5–1.0 point was usually reached after 3 months [ 96 , 205 , 206 ].…”