Evidence map›Paper›PMID 27271272›Full record

ArticlePharmaceutical research2016

Kinetics of Clobetasol-17-Propionate in Psoriatic Lesional and Non-Lesional Skin Assessed by Dermal Open Flow Microperfusion with Time and Space Resolution.

Manfred Bodenlenz, Christian Dragatin, Lisa Liebenberger, Bernd Tschapeller, Beate Boulgaropoulos, Thomas Augustin, Reingard Raml, Christina Gatschelhofer, Nathalie Wagner, Khaled Benkali and 3 more

3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Pharmaceutical research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
0.5field-weighted citation impact, top 34% 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.

NCT03613207 nacompletednot on this mapstarted 2018, after this paper: background citation

An Exploratory Pilot Study in Healthy Volunteers to Assess the Parameters for the Design of Bioequivalence Studies on Moderately Lipophilic, Moderately to Highly Protein Bound Drugs Using Dermal Open Flow Microperfusion (dOFM)

TypeinterventionalSponsorJoanneum Research Forschungsgesellschaft mbHRan2018 to 2018Enrolled6ConditionsDermatology/Skin - Other, Dermal Pharmacokinetic MeasurementsArmsDermal pharmacokinetic measurement, Lidocaine and prilocaine cream, Oraqix® gel, dOFM-System, Blood sampling
NCT03813030 nacompletednot on this mapstarted 2019, after this paper: background citation

An Exploratory Study in Healthy Volunteers to Investigate the Cross-talk Between Local Drug Concentrations in the Skin and Systemic Concentrations During Topical Bioequivalence Studies Using Dermal Sampling Techniques

TypeinterventionalSponsorJoanneum Research Forschungsgesellschaft mbHRan2019 to 2019Enrolled26ConditionsHealthy, Dermal Pharmacokinetic MeasurementArmsIntravenous infusion of lidocaine, Lidocaine 2.5% and Prilocaine 2.5% cream", USP (2.5% lidocaine, 2.5% prilocaine, Actavis Pharma incorporated, USA), Lidocorit 2%-Ampullen" (Gebro Pharma Gesellschaft mit beschränkter Haftung, Austria), Dermal open flow microperfusion, Dermal Microdialysis
NCT04050826 nacompletednot on this mapstarted 2019, after this paper: background citation

An Exploratory Study in Healthy Volunteers to Identify Factors Influencing Bioequivalence Studies on Moderately Lipophilic Drugs Using Dermal Open Flow Microperfusion (dOFM)

TypeinterventionalSponsorJoanneum Research Forschungsgesellschaft mbHRan2019 to 2020Enrolled20ConditionsHealthy, Dermal Pharmacokinetic MeasurementsArmsLidocaine 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA), Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA), Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany), Dermal open flow microperfusion, Blood sampling
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 21 citations in OpenAlex.

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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

13 authors at 3 institutions in 2 countries.

Manfred BodenlenzHEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria.
Christian DragatinHEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria.
Lisa LiebenbergerDivision of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.
Bernd TschapellerHEALTH - 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.
Thomas AugustinHEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria.
Reingard RamlHEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria.
Christina GatschelhoferHEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria.
Nathalie WagnerGalderma R&D, Sophia Antipolis, France.
Khaled BenkaliGalderma R&D, Sophia Antipolis, France.
Francois RonyGalderma R&D, Sophia Antipolis, France.
Thomas PieberHEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria.
Frank SinnerHEALTH - Institute for Biomedicine and Health Sciences, Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria. healthca@joanneum.at.
Joanneum Research · ATGalderma (France) · FRMedical University of Graz · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the kinetics of topically applied clobetasol-17-propionate (CP-17) in lesional and non-lesional psoriatic skin when released from a commercially available low-strength cream using in vivo dermal open-flow microperfusion (dOFM).

methodsTwelve patients received Dermovate® cream (CP-17, 0.05%) on small lesional and non-lesional skin test sites for 14 days, once daily. On day 1 and 14, dOFM samples were continuously taken in the dermis for 24 h post-dose and analyzed by LC-MS/MS. Probe depths were assessed by 50 MHz ultrasound scanning.

resultsMixed-effects modelling identified skin condition, treatment duration and probe-depth as kinetics determining variables. The time- and depth-resolved intradermal data revealed (i) slower penetration of CP-17 into lesional than into non-lesional skin, (ii) normalized (faster) skin penetration after repeated dosing, and (iii) no CP-17 accumulation within the dermis independently of the skin condition.

conclusionsIntradermal investigation of a highly lipophilic drug released from low-strength cream was successfully performed by using dOFM and timely and spatially, i.e., probe-depth dependent, resolved kinetic data were delivered. These data support the assumption that the thickened psoriatic stratum corneum might act as trap compartment which lowers the skin penetration rate for lipophilic topical drugs.

Indexed as

Administration, CutaneousAdultChromatography, LiquidClobetasolFemaleHumansKineticsMalePerfusionSkinSkin AbsorptionTandem Mass SpectrometryClobetasoldermal pharmacokineticslipophilic drugopen flow microperfusionskin penetrationtopical formulation

Identifiers

PMID27271272
PMCPMC4967091
OpenAlexW2418005450

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.