Evidence map›Paper›PMID 41667767›Full record

ArticleAAPS PharmSciTech2026

In Vitro Permeation Testing of Sunscreens using Reconstructed Human Skin versus Human Cadaver Skin Models.

Kartik R Roy, Apipa Wanasathop, Lijing Xu, Jiang Wang, Sergio G Coelho, Steven A Adah, Theresa M Michele, Patrick J Faustino, Muhammad Ashraf, Xiaoming Xu and 1 more

Abstract read
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In one paragraph

Article in AAPS PharmSciTech, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

Kartik R RoyOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD20993, WO64-1032, USA.ORCID http://orcid.org/0000-0002-9774-5687
Apipa WanasathopOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD20993, WO64-1032, USA.ORCID http://orcid.org/0000-0002-1173-0063
Lijing XuOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD20993, WO64-1032, USA.ORCID http://orcid.org/0009-0009-6447-0320
Jiang WangOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD20993, WO64-1032, USA.ORCID http://orcid.org/0000-0003-0165-3030
Sergio G CoelhoOffice of Nonprescription Drugs, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.ORCID http://orcid.org/0000-0002-4179-6776
Steven A AdahOffice of Nonprescription Drugs, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.ORCID http://orcid.org/0000-0002-1835-8444
Theresa M MicheleOffice of Nonprescription Drugs, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.ORCID http://orcid.org/0000-0003-0965-648X
Patrick J FaustinoOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD20993, WO64-1032, USA.ORCID http://orcid.org/0000-0002-7719-0813
Muhammad AshrafOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD20993, WO64-1032, USA.ORCID http://orcid.org/0000-0002-1375-3285
Xiaoming XuOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD20993, WO64-1032, USA.ORCID http://orcid.org/0000-0003-1672-0830
Yang YangOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD20993, WO64-1032, USA. Yang.Yang@fda.hhs.gov.ORCID http://orcid.org/0000-0002-7040-6829

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In vitro permeation testing (IVPT) is a method widely used to assess the skin permeation profiles of topical drug products for product development and regulatory evaluation. Various skin models serve as diffusion barriers in IVPT, including surgically excised human skin (EHS) and human cadaver skin (HCS). Limited EHS supply has led to the use of HCS in IVPT, but HCS shows variable skin permeation among donors, creating challenges in obtaining consistent results. To address these supply and variability issues, this study evaluated the potential of reconstructed human skin (RHS) as an alternative diffusion barrier for IVPT. Sunscreen (cream) permeation through four skin models were compared, including two HCS models and two RHS models with or without dermal layers. Among the tested skin models, EpiDermFT (RHS with dermal layers) exhibited consistent results for both intra-batch and inter-batch permeation. Additionally, EpiDermFT exhibited similar rank order of cumulative permeation compared to the HCS counterpart, whereas EpiDerm (RHS without dermal layers) exhibited greater sensitivity to pH changes in cream formulations than HCS models. These findings suggest that EpiDermFT has potential utility as a reliable alternative that provides comparable permeation results to HCS, whereas EpiDerm may serve as a sensitive tool to detect pH differences in topical formulations. However, to determine the broader applicability of RHS in IVPT, further investigations using diverse topical formulations across different dosage forms are necessary.

Indexed as

SkinSkin AbsorptionSunscreening AgentsAdministration, CutaneousCadaverDiffusionHumansHydrogen-Ion ConcentrationIn Vitro TechniquesModels, BiologicalPermeabilitySunscreening AgentsIVPTskin modelskin permeationsunscreen

Identifiers

PMID41667767

What OpenQuestion holds

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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.