Efficacy and Tolerability of Stable Hybrid Cooperative Complexes of High- and Low-Molecular Weight Hyaluronic Acid in Asian Patients: An Open-Label Study
- PMID: 40921777
- DOI: 10.1007/s00266-025-05188-x
Efficacy and Tolerability of Stable Hybrid Cooperative Complexes of High- and Low-Molecular Weight Hyaluronic Acid in Asian Patients: An Open-Label Study
Abstract
Background: Few studies of Profhilo® for facial skin regeneration in Asian patients exist.
Aims: The efficacy and safety of Profhilo® in regenerating facial skin in Asian females were investigated in a single-center study.
Patients/methods: Patients were treated with Profhilo® on Weeks 0 and 4 and followed up on Week 12. Assessments included three-dimensional photography, Facial Volume Loss Scale (FVLS), Wrinkle Severity Rating Scale (WSRS), superficial skin hydration, transepidermal water loss (TEWL), skin elasticity, and self-rated product tolerability.
Results: Of 30 enrolled Chinese females (aged 38.0-60.0 years), outcome data were analyzed for 28 and 26 patients at Weeks 0-4 and follow-up, respectively, aside from skin hydration (N = 8 and N = 6, respectively). Treatment led to a FVLS (P = 0.0150), WSRS (P = 0.0057), and R3 ("tiring effect" of the skin; P = 0.0424) decrease over time, but pairwise time point comparisons for these measures were not significant (NS). A trend toward a decrease in F1 (elasticity) over time occurred but was NS. A statistically significant improvement in superficial skin hydration and TEWL occurred over time (P = 0.0010 and P = 0.0055, respectively) and, specifically, at Week 12 versus baseline (P = 0.0034 and P = 0.0029, respectively). Patients reported "good" product tolerability.
Conclusions: Profhilo® for facial skin regeneration was efficacious and tolerable in Chinese patients. This study contributes to the limited available clinical data with Profhilo® and Asian facial skin regeneration. Profhilo® significantly improved superficial skin hydration and transepidermal water loss in Chinese patients. Profhilo® was well tolerated in Chinese patients.
Level of evidence iv: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
Keywords: Asian; Face; Hyaluronic acid; Hybrid cooperative complexes; Profhilo®; Skin regeneration.
© 2025. The Author(s).
Conflict of interest statement
Declarations. Conflict of interest: C.C. and F.G. are employees of IBSA Farmaceutici Italia Srl. The other authors declare that this research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Ethical Approval: Study procedures were performed in accordance with the Declaration of Helsinki (as revised in 2013) and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Guideline on Good Clinical Practice. An Institutional Review Board approved the study at the National Skin Centre, Singapore. Informed Consent: All study patients provided their written informed consent before enrollment to participate in the study and to publish its findings.
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