Clinical, Cosmetic and Investigational Dermatology (Apr 2023)
Evaluation of the Performance and Tolerance of the Combination of an HA-based Filler with Tri-Hyal Technology and a Skin Biorevitalizer on Skin Aging Parameters
Abstract
Ferial Fanian,1 Valerie Philippon,2 Mihai Gorj,3 Elena Rumyantseva Mathey,3 Maxence Caillens,4 Ranesha Goorochurn,5 Shannel Curic,1 Philippe Humbert6 1FILLMED Laboratories, Paris, France; 2Private Clinic, Boulogne Billancourt, France; 3Private Clinic, Paris, France; 4Private Clinic, Sarcelles, France; 5Dermo Dev Partners, Paris, France; 6Private Clinic, Ornans, FranceCorrespondence: Ferial Fanian, Scientific Department, FILLMED Laboratories, 2 rue de Lisbonne, Paris, 75008, France, Tel +33 6 73 76 18 20, Email [email protected]: Biorevitalization solutions contain numerous nutritive compounds to improve skin quality. Dermal fillers like HA (hyaluronic acid), depending on rheological characteristics, are used to fill large static defaults with a sustained long-term efficacy. Treatments with either dermal filler or biorevitalization solutions alone are not enough to bring a global facial aging approach.Objective: To demonstrate the anti-aging performance and safety of a new protocol, BIONUTRILIFT, which combined an HA-based filler with Tri-Hyal technology and a skin biorevitalizer, to target the skin quality and wrinkles correction at the same time.Materials and Methods: Eligible subjects were enrolled based on a score of 2, 3, 4, or 5 on Bazin cheek folds wrinkle scale. Safety outcomes measured were immediate and local tolerability. Performance outcomes measured included: proportion of subjects in whom the severity of cheeks folds, nasolabial folds, marionette lines, upper lip wrinkles and skin radiance remained at least one point below the baseline measurement (Bazin scale) Global Aesthetic Improvement Scale scores by subjects and investigators.Results: In performance analyses with the combined protocol, skin radiance and cheek folds wrinkle correction sustained during the four-month study and decrease by 61% and 55%, respectively. 96% and 77% of subjects respectively showed at least a one-point decrease in the mean skin radiance score and Bazin score compared with baseline. Interestingly, the BIONUTRILIFT protocol showed the distance effect of vector A (cheek injection) and vector B (mandibular injection) on perioral zone and remained significant even 120 days after injections. Adverse events (AEs) were consistent with the expected AEsthat occurred after dermal injections. No serious AEswere recorded.Conclusion: BIONUTRILIFT may satisfy the subjects’ demand by obtaining in the same session a simple, personalized, noninvasive, atraumatic, and reproductible technique.Keywords: dermal filler, biorevitalization, combined protocol, distance effect