Study shows safety of Neauvia Stimulate in patients with autoimmune thyroid diseases

Neauvia - a leading pharmaceutical company specialising in Smart Combination Therapy that combines dermal fillers, energy-based devices, and cosmeceuticals - has announced the results of a comprehensive safety evaluation of its Neauvia Stimulate injectable product in patients with the autoimmune thyroid disease Hashimoto's.

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 study^1-2, 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.

"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," says the aesthetic doctor Dr Lisa Dinley. "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, especially important in patients with Autoimmune diseases. So, this group of patients can be treated safely with the Neauvia range."

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