Evidence map›Paper›PMID 37367111›Full record

ArticleGels (Basel, Switzerland)2023

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.

Paweł Kubik, Daniela Gallo, Maria Laura Tanda, Jerzy Jankau, Raffaele Rauso, Wojciech Gruszczyński, Aleksandra Pawłowska, Paweł Chrapczyński, Maciej Malinowski, Dariusz Grzanka and 10 more

Open access · goldAbstract read
In one paragraph

Article in Gels (Basel, Switzerland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 7 institutions in 3 countries.

Paweł KubikK-LAB Badania i Rozwój, 81-312 Gdynia, Poland.
Daniela GalloEndocrine Unit, Department of Medicine and Surgery, University of Insubria, ASST dei Sette Laghi, 21100 Varese, Italy.ORCID 0000-0002-1873-3048
Maria Laura TandaEndocrine Unit, Department of Medicine and Surgery, University of Insubria, ASST dei Sette Laghi, 21100 Varese, Italy.ORCID 0000-0001-7551-1751
Jerzy JankauDepartment of Plastic Surgery, Medical University of Gdansk, 80-210 Gdańsk, Poland.
Raffaele RausoMaxillofacial Surgery Unit, University of Campania "Luigi Vanvitelli", 80138 Naples, Italy.ORCID 0000-0002-4497-3563
Wojciech GruszczyńskiK-LAB Badania i Rozwój, 81-312 Gdynia, Poland.
Aleksandra PawłowskaK-LAB Badania i Rozwój, 81-312 Gdynia, Poland.
Paweł ChrapczyńskiK-LAB Badania i Rozwój, 81-312 Gdynia, Poland.
Maciej MalinowskiK-LAB Badania i Rozwój, 81-312 Gdynia, Poland.
Dariusz GrzankaDepartment of Clinical Pathomorphology, Nicolaus Copernicus University, 85-094 Bydgoszcz, Poland.ORCID 0000-0002-0416-7583
Marta SmolińskaDepartment of Clinical Pathomorphology, Nicolaus Copernicus University, 85-094 Bydgoszcz, Poland.ORCID 0000-0003-1327-7087
Paulina AntosikDepartment of Clinical Pathomorphology, Nicolaus Copernicus University, 85-094 Bydgoszcz, Poland.
Maria-Luiza PiesiakówK-LAB Badania i Rozwój, 81-312 Gdynia, Poland.
Bartłomiej ŁukasikMedical Department, Matex Lab Switzerland SA, 1228 Geneve, Switzerland.
Agnieszka Pawłowska-KubikDivision of History & Philosophy of Medical Sciences, Medical University of Gdansk, 80-210 Gdańsk, Poland.ORCID 0000-0002-7379-8645
Giorgio StabileDepartment of Clinical Dermatology, Università Vita-Salute San Raffaele, 20132 Milan, Italy.
Stefania GuidaDepartment of Clinical Dermatology, Università Vita-Salute San Raffaele, 20132 Milan, Italy.
Łukasz KodłubańskiDepartment of Human Rights and Intellectual Property Law, University of Gdansk, 80-309 Gdansk, Poland.ORCID 0000-0001-7340-6552
Tom DecatesDepartment of Dermatology, Erasmus Medical Center, 3000 Rotterdam, The Netherlands.ORCID 0000-0002-1929-2010
Nicola ZerbinatiDermatologic Unit, Department of Medicine and Surgery, University of Insubria, 21100 Varese, Italy.
Nicolaus Copernicus University · PLUniversity of Insubria · ITGdańsk Medical University · PLVita-Salute San Raffaele University · ITErasmus MC · NLUniversity of Campania "Luigi Vanvitelli" · ITUniversity of Gdańsk · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this study was to test the effect of hyaluronic acid cross-linked with polyethylene glycol containing micronized portions of calcium hydroxyapatite (Neauvia Stimulate) on both local tissue and systemic consequences, which are crucial from the perspective of long-term safety, in patients suffering from Hashimoto's disease. This most common autoimmune disease is a frequently mentioned contraindication to the use of fillers based on hyaluronic acid as well as biostimulants based on calcium hydroxyapatite. Broad-spectrum aspects of histopathology were analyzed to identify key features of inflammatory infiltration before the procedure and 5, 21, and 150 days after the procedure. A statistically significant effect on the reduction of the intensity of the inflammatory infiltration in the tissue in relation to the state before the procedure was demonstrated, combined with a reduction in the occurrence of both antigen-recognizing (CD4) and cytotoxic (CD8) T lymphocytes. With complete statistical certainty, it was demonstrated that the treatment with Neauvia Stimulate had no effect on the levels of these antibodies. All this corresponds with the risk analysis that showed no alarming symptoms during the time of observation. The choice of hyaluronic acid fillers cross-linked with polyethylene glycol should be considered justified and safe in the case of patients suffering from Hashimoto's disease.

Indexed as

autoimmunityHashimoto’shyaluronic acid fillersNeauvia Stimulate injectable productNGelpolyethylene glycolthyroid

Identifiers

PMID37367111
PMCPMC10297656
OpenAlexW4378575237

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.