Evidence map›Paper›PMID 32989514›Full record

ArticlePharmaceutical research2020

Variability of Skin Pharmacokinetic Data: Insights from a Topical Bioequivalence Study Using Dermal Open Flow Microperfusion.

Manfred Bodenlenz, Thomas Augustin, Thomas Birngruber, Katrin I Tiffner, Beate Boulgaropoulos, Simon Schwingenschuh, Sam G Raney, Elena Rantou, Frank Sinner

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pharmaceutical research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04592016 (A Single Center, Open-label, Clinical Study to Evaluate the Ability of Dermal Open Flow Microperfusion), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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.

NCT04592016 nacompletednot on this map

A Single Center, Open-label, Clinical Study to Evaluate the Ability of Dermal Open Flow Microperfusion (dOFM) for Bioequivalence Testing of Topically Applied Diclofenac Sodium Products in Healthy Subjects

TypeinterventionalSponsorJoanneum Research Forschungsgesellschaft mbHRan2020 to 2021Enrolled22ConditionsHealthyArmsVoltaren - Diclofenac sodium gel 1% (GSK, USA), Pennsaid 2 % Topical Solution (Horizon Therapeutics, USA), Diclofenac sodium gel 1% (Perrigo, USA), Dermal open flow microperfusion - Pilot, Dermal open flow microperfusion - Pivotal
3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Review
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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

9 authors.

Manfred BodenlenzHEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria.
Thomas AugustinHEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria.
Thomas BirngruberHEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria.
Katrin I TiffnerHEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria.
Beate BoulgaropoulosHEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria.
Simon SchwingenschuhHEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria.
Sam G RaneyDivision of Therapeutic Performance Office of Research and Standards Office of Generic Drugs, United States (U.S.) Food and Drug Administration, 10903 New Hampshire Avenue, MD, 20993, Silver Spring, USA.
Elena RantouDivision of Biostatistics VIII, Office of Biostatistics, Office of Translational Sciences, United States (U.S.) Food and Drug Administration, 10903 New Hampshire Avenue, MD, 20993, Silver Spring, USA.
Frank SinnerHEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria. healthca@joanneum.at.ORCID http://orcid.org/0000-0002-9292-4512

Funding

Development of a Universal Bioequivalence Test Method for Topical Drugs using dOFMU01FD005861 · FDA · JOANNEUM RESEARCH FORSCHUNGSGESELLSCHAFT MBH · PI SINNER, FRANK · 2016 to 2018
$2.0M
NOVEL METHODOLOGIES AND IVIVC APPROACHES TO ASSESS BIOEQUIVALENCE OF TOPICAL DRUGU01FD004946 · FDA · JOANNEUM RESEARCH FORSCHUNGSGESELLSCHAFT MBH · PI SINNER, FRANK · 2013 to 2014
$750k
FDA HHS U01 FD004946FDA HHS U01 FD005861U.S. Food and Drug Administration 1U01FD004946U.S. Food and Drug Administration 1U01FD005861
6 · The paper itself

Abstract

purposeDermal open flow microperfusion (dOFM) has previously demonstrated its utility to assess the bioequivalence (BE) of topical drug products in a clinical study. We aimed to characterize the sources of variability in the dermal pharmacokinetic data from that study.

methodsExploratory statistical analyses were performed with multivariate data from a clinical dOFM-study in 20 healthy adults evaluating the BE, or lack thereof, of Austrian test (T) and U.S. reference (R) acyclovir cream, 5% products.

resultsThe overall variability of logAUC values (CV: 39% for R and 45% for T) was dominated by inter-subject variability (R: 82%, T: 91%) which correlated best with the subject's skin conductance. Intra-subject variability was 18% (R) and 9% (T) of the overall variability; skin treatment sites or methodological factors did not significantly contribute to that variability.

conclusionsInter-subject variability was the major component of overall variability for acyclovir, and treatment site location did not significantly influence intra-subject variability. These results support a dOFM BE study design with T and R products assessed simultaneously on the same subject, where T and R treatment sites do not necessarily need to be next to each other. Localized variation in skin microstructure may be primarily responsible for intra-subject variability.

Indexed as

AcyclovirAdministration, CutaneousAdultFemaleHumansMaleMiddle AgedPerfusionReproducibility of ResultsSkinSkin AbsorptionTherapeutic EquivalencyAcycloviracyclovirdermal open flow microperfusioninter- and intra-subject variabilitymicrodialysisskin pharmacokineticsTopical bioequivalence

Identifiers

PMID32989514
PMCPMC7522073

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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 OpenQuestion graph.