ArticleJournal of cosmetic dermatology2026
Comprehensive Analysis of Free BDPE Content in Commercial Hyaluronic Acid Fillers: Implications for Safety Assessment and Regulatory Standards.
Article in Journal of cosmetic dermatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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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.
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.
Who cites it
3 citing papers in PubMed.
- Six-Month Changes in Periorbital and Perioral Wrinkles and Facial Skin Quality following Low-Cross-Linked Hyaluronic Acid.Dermatology and therapy · 2026Article
- The PATH Protocol for Integrated Facial Rejuvenation: A Preliminary Three-Patient Case Report Series and Narrative Review of the Literature.Reports (MDPI) · 2026Article
- Comprehensive Analysis of Free BDPE Content in Commercial Hyaluronic Acid Fillers: Implications for Safety Assessment and Regulatory Standards.Journal of cosmetic dermatology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough manufacturers of 1,4-butanediol diglycidyl ether (BDDE)-cross-linked hyaluronic acid (HA) fillers assert effective removal of unreacted BDDE, the hydrolyzed derivative 3,3'-(butane-1,4-diyl)bis(oxy)bis(propane-1,2-diol) (BDPE) is routinely monitored, despite possessing structural features associated with sensitization potential.
aimsTo quantify free BDPE content across commercially available HA dermal fillers and assess potential safety implications. MATERIALS/
methodsA validated liquid chromatography-tandem mass spectrometry method was developed to quantify BDPE levels in 38 commercial HA filler products from seven major manufacturers. In silico prediction models were used to evaluate the skin sensitization and irritation potential of BDPE.
resultsBDDE levels were non-detectable in all analyzed products. By contrast, free BDPE content varied markedly, with over 1000-fold differences observed between products, indicating substantial variability in purification efficiency across manufacturing processes. Considerable variability was also identified among Food and Drug Administration-approved products, with some containing BDPE concentrations exceeding 100 ppm. Conversely, several products exhibited low BDPE levels ranging from 0.1 to 2.5 ppm, further highlighting inconsistencies in manufacturing control.
conclusionsIndustry claims regarding complete cross-linker removal may fail to account for the persistence of BDPE species. The substantial inter-product variability observed in this study suggests inadequate process control among manufacturers. Given the structural similarity of BDPE to known sensitizers and the direct dermal injection route that circumvents the skin barrier, free BDPE should be designated a critical quality attribute with defined acceptance limits. These findings suggest that BDPE can be reduced to concentrations below 2.5 ppm, supporting the need for stricter manufacturing standards.
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Registered trials
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 Socratic graph.