On the Peg
We explore the results of a study demonstrating the safety of Neauvia Stimulate in patients with autoimmune thyroid diseases
Neauvia has announced the results of a comprehensive evaluation of the safety of its Neauvia Stimulate injectable product in patients with the autoimmune thyroid disease Hashimoto’s.
The study1-2, conducted by a team of researchers and 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, which 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 study 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, a hyaluronic acid cross-linked with polyethylene glycol containing micronised portions of calcium hydroxyapatite (26 mg/ml, L-proline, glycine, 1% CaHA).
The patients were evaluated before the treatment and at five, 21 and 150 days post-treatment to assess inflammatory infiltration.
Key findings from the study 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 clinical outcomes of this study 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, along with their long-lasting results. Importantly, there are no substantive or registered contraindications to the use of PEGylated hyaluronic acid fillers in patients with Hashimoto’s disease.
The study further highlights the immunomodulatory effect of PEG, which positively contributes to the safety profile of the filler. Additionally, the stimulatory effect achieved by the calcium hydroxyapatite particles adds to the overall positive outcomes.
The results of this evaluation further reinforce Neauvia’s dedication to delivering high-quality products backed by extensive clinical evidence.
Dr Lisa Dinley says, “I love using stimulate as it not only volumises the tissues it also stimulates the fibroblasts with the addition of 1% Calcium hydroxyapatite, which improves the skin quality, particularly useful in older and damaged skin.
Additionally, Neauvia fillers are unique due to the PEG smart cross-linking technology which confers a stealth-like property to the filler, meaning that patients do not get an immune or inflammatory reaction, which is especially important in patients with autoimmune diseases. So, this group of patients can be treated safely with the Neauvia range.”
Resources
1. Kubik, P; Gallo, D.; Tanda, M.L.; Jankau, J.; Rauso, R.; Gruszczynski, W.; Pawlowska, A.; Chrapczynski, P.; Malinowski, M.; Grzanka, D.; Smolinska, M.; Antosik, P.; Piesiakow, M.-L.; Lukasik, B.; Pawlowska-Kubik, A.; Stabile, G.; Guida, S.; Kodlubanski, L.; 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 https://www.mdpi.com/2310-2861/9/6/440