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Authors
Thurston, Archie W. Jr
Osborne, David W.
Snyder, Scott
Higham, Robert C.
Burnett, Patrick
Berk, David R.
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Clinical Trials BETA
Clinical trials referenced in this document:
nct04279119 at ClinicalTrials.govnct03392168 at ClinicalTrials.govDocuments that mention this clinical trial
Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies
https://doi.org/10.1007/s40257-022-00741-9
nct04211363 at ClinicalTrials.govDocuments that mention this clinical trial
Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies
https://doi.org/10.1007/s40257-022-00741-9
nct04211389 at ClinicalTrials.govDocuments that mention this clinical trial
Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies
https://doi.org/10.1007/s40257-022-00741-9
Documents that mention this clinical trial
Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies
https://doi.org/10.1007/s40257-022-00741-9
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Funding
Funding for this research was provided by:
Arcutis Biotherapeutics, Inc.
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More Information
Article History
Accepted: 20 October 2022
First Online: 24 November 2022
Declarations
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: The study was funded by Arcutis Biotherapeutics Inc.
: Archie W. Thurston Jr is an employee of Toxicology Solutions and a consultant with Arcutis Biotherapeutics, Inc. David R. Berk, David W. Osborne, Scott Snyder, Robert C. Higham, and Patrick Burnett are employees of Arcutis Biotherapeutics, Inc.
: These studies were conducted in accordance with the ethical principles set forth in the Declaration of Helsinki and the International Council for Harmonization harmonized tripartite guideline regarding Good Clinical Practice (2016 guidance). Approval by the Investigational Review Board was obtained from each investigator’s institution, and written informed consent or assent was obtained before enrollment. In the skin-level assessment from the phase I/IIa study (Study 101), the protocol was approved by Research Review Board, Inc, Richmond Hill, ON, Canada, for all sites.
: Written informed consent or assent was obtained before enrollment in each of the studies included in this manuscript.
: Not applicable.
: Data collected for these studies will be made available to others. Proposals for data requests will be reviewed and considered for sharing following approval of the indication. Information about when data availability will begin and end will be provided following approval of the indication.
: Not applicable.
