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PEGylated HA filler safe for patients with Hashimoto's disease, finds study


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No registered contraindications to the use of the Neauvia Stimulate injectable product in patients with Hashimoto's disease have been found in a comprehensive safety evaluation.


The study was conducted by Neauvia, a leading pharmaceutical company specialising in Smart Combination Therapy that combines dermal fillers, energy-based devices and cosmeceuticals.


Neauvia Stimulate is a hyaluronic acid cross-linked with polyethylene glycol containing micronised portions of calcium hydroxyapatite (26 mg/ml, L-proline, glycine, 1% CaHA).


The study1-2, published at the end of May 2023, aimed to assess the impact of the PEGylated HA filler on both the local tissues and systemic consequences. These are crucial from a long-term safety perspective in patients suffering from Hashimoto's disease, an autoimmune disorder that primarily affects the thyroid gland.


The research analysed the histopathological examinations and conducted a retrospective analysis of medical records of 15 Hashimoto's thyroiditis patients who received 2.0 ml of Neauvia Stimulate.


The patients were evaluated beforehand and at five, 21- and 150 days post-treatment to assess inflammatory infiltration.


Key study findings include a significant decrease in the overall local inflammatory infiltrate at day 21 compared to baseline. The presence of T-lymphocytes (CD4 & CD8 antigens) and B-lymphocytes (CD20) also decreased.


Notably, no correlation was found between the treatment and the levels of anti-TPO (anti-thyroid peroxidase) and anti-TG (antithyroglobulin) antibodies. Based on the study's clinical outcomes and consistent with previously published data, no complications, such as granulomas or foreign body reactions, were observed.


These results confirm the high safety profile and biocompatibility of PEGylated HA fillers. Importantly, there are no substantive or registered contraindications to the use of PEGylated hyaluronic acid fillers in patients with Hashimoto's disease. The study also highlights the immunomodulatory effect of PEG, which positively contributes to the filler's safety profile.


Additionally, the stimulatory effect achieved by the calcium hydroxyapatite particles aids overall positive outcomes.


References


1.Kubik, P.; Gallo, D.; Tanda, M.L.; Jankau, J.; Rauso, R.; Gruszczynski, W.; Pawłowska, A.; Chrapczynski, P.; Malinowski, M.; Grzanka, D.; Smolinska, M.; Antosik, P.; Piesiaków, M.-L.; Łukasik, B.; Pawłowska-Kubik, A.; Stabile, G.; Guida, S.; Kodłubanski, Ł.; Decates, T.; Zerbinati. N. Evaluation of the Safety of Neauvia Stimulate Injectable Product in Patients with Autoimmune Thyroid Diseases Based on Histopathological Examinations and Retrospective Analysis of Medical Records. Gels 2023, 9, 440. https://doi.org/10.3390/gels9060440

2.Open access available at mdpi.com/2310-2861/9/6/440



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