Efficacy and tolerability of Profhilo® Structura intended to restore lateral cheek fat compartment: An observational pilot study
Abstract Background and Aims Hyaluronic acid (HA)‐based injections are used worldwide to improve skin defects associated with aging and ultraviolet light/environmental exposure. HA formulations developed according to molecular weight or with additional components, for example, cross‐linking reagents...
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| Format: | Article |
| Language: | English |
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Wiley
2024-01-01
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| Series: | Health Science Reports |
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| Online Access: | https://doi.org/10.1002/hsr2.1743 |
| _version_ | 1797331694209990656 |
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| author | Adele Sparavigna Franco Grimolizzi Clara Cigni Roberto Lualdi Gilberto Bellia |
| author_facet | Adele Sparavigna Franco Grimolizzi Clara Cigni Roberto Lualdi Gilberto Bellia |
| author_sort | Adele Sparavigna |
| collection | DOAJ |
| description | Abstract Background and Aims Hyaluronic acid (HA)‐based injections are used worldwide to improve skin defects associated with aging and ultraviolet light/environmental exposure. HA formulations developed according to molecular weight or with additional components, for example, cross‐linking reagents, are limited by their low biological activity and concentration limit. NAHYCO™ technology has enabled the production of hybrid cooperative complexes (HCCs) of low and high molecular weight HA. Developed for injection into the fat compartments of the face and previously demonstrating potential benefits for adipose tissue restoration, Profhilo Structura® is a new 2 mL HCC formulation comprising low molecular weight HA (45 mg/mL) and high molecular weight HA (45 mg/mL). To evaluate the efficacy and tolerability of Profhilo Structura® to restore adipose tissue compartments in the lateral cheek fat compartment. Methods Fifty healthy enrolled subjects received two injections, 1 month apart, and were evaluated 3 months posttreatment. Investigators performed clinical evaluations (Facial Volume Loss Scale [FVLS] and Wrinkle Severity Rating Scale [WSRS]) at different time points. Subjects also completed self‐evaluation assessments following treatment. Results A significant improvement in FVLS and WSRS clinical scores after the first treatment was observed; treatment benefit was maintained 3 months after treatment completion and confirmed by subject self‐assessment. Most participants reported an improvement, particularly a marked reduction of wrinkles and increased skin firmness. No serious adverse events were reported, confirming the excellent safety profile of HCC injectable devices. Conclusions Overall, the study highlighted the efficacy and tolerability of the studied medical device proving its effect on adipose tissue. |
| first_indexed | 2024-03-08T07:38:10Z |
| format | Article |
| id | doaj.art-7b9eb8ba97e349daadb1b5a5726f32eb |
| institution | Directory Open Access Journal |
| issn | 2398-8835 |
| language | English |
| last_indexed | 2024-03-08T07:38:10Z |
| publishDate | 2024-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Health Science Reports |
| spelling | doaj.art-7b9eb8ba97e349daadb1b5a5726f32eb2024-02-02T18:04:59ZengWileyHealth Science Reports2398-88352024-01-0171n/an/a10.1002/hsr2.1743Efficacy and tolerability of Profhilo® Structura intended to restore lateral cheek fat compartment: An observational pilot studyAdele Sparavigna0Franco Grimolizzi1Clara Cigni2Roberto Lualdi3Gilberto Bellia4DERMING S.r.l. Milano ItalyIBSA Farmaceutici Italia Lodi ItalyIBSA Farmaceutici Italia Lodi ItalyDERMING S.r.l. Milano ItalyIBSA Farmaceutici Italia Lodi ItalyAbstract Background and Aims Hyaluronic acid (HA)‐based injections are used worldwide to improve skin defects associated with aging and ultraviolet light/environmental exposure. HA formulations developed according to molecular weight or with additional components, for example, cross‐linking reagents, are limited by their low biological activity and concentration limit. NAHYCO™ technology has enabled the production of hybrid cooperative complexes (HCCs) of low and high molecular weight HA. Developed for injection into the fat compartments of the face and previously demonstrating potential benefits for adipose tissue restoration, Profhilo Structura® is a new 2 mL HCC formulation comprising low molecular weight HA (45 mg/mL) and high molecular weight HA (45 mg/mL). To evaluate the efficacy and tolerability of Profhilo Structura® to restore adipose tissue compartments in the lateral cheek fat compartment. Methods Fifty healthy enrolled subjects received two injections, 1 month apart, and were evaluated 3 months posttreatment. Investigators performed clinical evaluations (Facial Volume Loss Scale [FVLS] and Wrinkle Severity Rating Scale [WSRS]) at different time points. Subjects also completed self‐evaluation assessments following treatment. Results A significant improvement in FVLS and WSRS clinical scores after the first treatment was observed; treatment benefit was maintained 3 months after treatment completion and confirmed by subject self‐assessment. Most participants reported an improvement, particularly a marked reduction of wrinkles and increased skin firmness. No serious adverse events were reported, confirming the excellent safety profile of HCC injectable devices. Conclusions Overall, the study highlighted the efficacy and tolerability of the studied medical device proving its effect on adipose tissue.https://doi.org/10.1002/hsr2.1743face fat compartmenthyaluronic acidhybrid cooperative complexessafety |
| spellingShingle | Adele Sparavigna Franco Grimolizzi Clara Cigni Roberto Lualdi Gilberto Bellia Efficacy and tolerability of Profhilo® Structura intended to restore lateral cheek fat compartment: An observational pilot study Health Science Reports face fat compartment hyaluronic acid hybrid cooperative complexes safety |
| title | Efficacy and tolerability of Profhilo® Structura intended to restore lateral cheek fat compartment: An observational pilot study |
| title_full | Efficacy and tolerability of Profhilo® Structura intended to restore lateral cheek fat compartment: An observational pilot study |
| title_fullStr | Efficacy and tolerability of Profhilo® Structura intended to restore lateral cheek fat compartment: An observational pilot study |
| title_full_unstemmed | Efficacy and tolerability of Profhilo® Structura intended to restore lateral cheek fat compartment: An observational pilot study |
| title_short | Efficacy and tolerability of Profhilo® Structura intended to restore lateral cheek fat compartment: An observational pilot study |
| title_sort | efficacy and tolerability of profhilo r structura intended to restore lateral cheek fat compartment an observational pilot study |
| topic | face fat compartment hyaluronic acid hybrid cooperative complexes safety |
| url | https://doi.org/10.1002/hsr2.1743 |
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