Journal of cosmetic dermatology · 2025
Hyaluronic Acid Hybrid Cooperative Complexes Nearing 10 Years of Use: Update on Safety Assessment Based on Post-Marketing Surveillance Data.
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Salti Giovanni, Tateo Antonello, Cassuto Daniel, Arrigoni Francesca, Godina Chiara, Mazzola Federica, Cigni Clara, Grimolizzi Franco, Bellia Gilberto
Аннотация
BACKGROUND: Hybrid cooperative complex hyaluronic acid (HCC HA) is a novel, widely used injectable developed using the patented NAHYCO Hybrid Technology for the treatment of the face and body, respectively.
AIM: To examine the safety profile of HCC HA from global post-marketing surveillance data.
METHODS: Post-marketing adverse events (AEs) reported for HCC HA injected to the face (Profhilo, HCC-HAPROF, IBSA Farmaceutici Italia Srl, Italy) from January 1, 2018 to October 31, 2023 and to the body (Profhilo Body, HCC-HAPROF-B, IBSA Farmaceutici Italia Srl, Italy) from January 1, 2020 to October 31, 2023 were analyzed. Patient exposure and the proportion of exposed patients with a safety complaint were also estimated.
RESULTS: The total number of patients exposed to HCC-HAPROF and HCC-HAPROF-B globally was projected to be 1 091 956 and 27 692, respectively. There was a total of 371 AEs recorded for HCC-HAPROF, and 11 AEs reported for HCC-HAPROF-B, corresponding to 0.034% and 0.040% of the patients, respectively. The most common AEs were edema, erythema, and discomfort, which are consistent with the manner and location of administration, and the AEs are frequently reported following treatment. The proportion of exposed patients with a safety complaint was low, with 0.026%-0.050% and 0%-0.013% of patients exposed to HCC-HAPROF or HCC-HAPROF-B experiencing a safety complaint, respectively.
CONCLUSIONS: Post-marketing surveillance indicated favorable safety profiles for HCC-HAPROF and HCC-HAPROF-, with the most common AEs expected and/or related to the method or site of administration.
AIM: To examine the safety profile of HCC HA from global post-marketing surveillance data.
METHODS: Post-marketing adverse events (AEs) reported for HCC HA injected to the face (Profhilo, HCC-HAPROF, IBSA Farmaceutici Italia Srl, Italy) from January 1, 2018 to October 31, 2023 and to the body (Profhilo Body, HCC-HAPROF-B, IBSA Farmaceutici Italia Srl, Italy) from January 1, 2020 to October 31, 2023 were analyzed. Patient exposure and the proportion of exposed patients with a safety complaint were also estimated.
RESULTS: The total number of patients exposed to HCC-HAPROF and HCC-HAPROF-B globally was projected to be 1 091 956 and 27 692, respectively. There was a total of 371 AEs recorded for HCC-HAPROF, and 11 AEs reported for HCC-HAPROF-B, corresponding to 0.034% and 0.040% of the patients, respectively. The most common AEs were edema, erythema, and discomfort, which are consistent with the manner and location of administration, and the AEs are frequently reported following treatment. The proportion of exposed patients with a safety complaint was low, with 0.026%-0.050% and 0%-0.013% of patients exposed to HCC-HAPROF or HCC-HAPROF-B experiencing a safety complaint, respectively.
CONCLUSIONS: Post-marketing surveillance indicated favorable safety profiles for HCC-HAPROF and HCC-HAPROF-, with the most common AEs expected and/or related to the method or site of administration.