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Gazzetta Medica Italiana - Archivio per le Scienze Mediche 2022 July-August;181(7-8):487-95

DOI: 10.23736/S0393-3660.22.04826-4

Copyright © 2022 EDIZIONI MINERVA MEDICA

language: English

Hybrid cooperative complexes of high and low molecular weight hyaluronans (96 mg/3 mL) for the treatment of skin laxity of the inner arm and abdomen

Adele SPARAVIGNA 1 , Danilo MUSELLA 2, Marco CICERONE 2, Andrea M. GIORI 2, Gilberto BELLIA 2

1 DERMING S.r.l., Milan, Italy; 2 IBSA Farmaceutici Italia, Lodi, Italy



BACKGROUND: The study was designed to evaluate the efficacy and safety of Profhilo® Body, a HA-based medical device, for the treatment of inner arm and abdomen laxity. The study has been performed in a single center, in healthy woman volunteers presenting a mild to moderate arm and abdomen laxity. The treatment consisted in two injection sessions, one month apart. 3mL of the studied medical device were administered for each brachial zone and 3mL for the abdomen.
METHODS: The efficacy was assessed by clinical and multilevel instrumental evaluations, over three visits: at the first injection (T0); at the second injection (after one month: T1) and 4 months after the first injection. At the end of the study, the volunteers were asked to fill a questionnaire for their self-evaluation of efficacy and tolerability.
RESULTS: The results highlighted the efficacy, both at clinical and instrumental levels of the applications, with aesthetic results already detectable after the first injection and maintained at the subsequent and last visit. The ameliorations detected by the investigators and instrumentations were confirmed by subjects’ self-evaluation. Importantly, all these positive effects were obtained with good to excellent tolerability as judged by both investigators and subjects.
CONCLUSIONS: The present study shows that the treatment with the studied medical device was safe and efficacious for the treatment of mild to moderate inner arm and abdomen skin roughness and laxity.


KEY WORDS: Sin diseases; Hyaluronic acid; Arm; Abdomen

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