Svendsen, Mathias Tiedemann https://orcid.org/0000-0002-4317-0873
Feldman, Steven R.
Möller, Sören
Kongstad, Line Planck
Andersen, Klaus Ejner
Funding for this research was provided by:
LEO Fondet
Odense Universitetshospital
Robert Wehnerts og Kirsten Wehnerts Fond
Psoriasis Research Foundation
Jeweler A.L. Rasmussens Memorial Foundation
Article History
Received: 15 March 2021
Accepted: 7 October 2021
First Online: 25 October 2021
Declarations
:
: All participants will be informed that the purpose of the study is to investigate how psoriasis improves with topical drugs used in a real-life setting. The study will be performed in accordance with the ethical principles in the Helsinki Declaration [].Participation in the study will not expose participants to more risk of side-effects than receiving standard of care treatment.Topical corticosteroids and calcipotriol are safe and effective when they are used as prescribed [, ]. However, if the patient experiences lack of efficacy from the prescribed treatment with topical corticosteroids-containing antipsoriatic drugs, this may be due to non-adherence. If the clinician is not attentive to this, the next step will be to subject the patient to treatments that carry a risk of skin cancer or burns (for example, narrow-band UVB phototherapy treatment), treatments with potentially severe side-effects such as severe immunosuppression, pancytopenia, and liver damage (for example, methotrexate), and finally cost-intensive treatments without knowledge of long-term side-effects (for example, biologic treatments or apremilast).
: Ethical approval has been obtained by the Regional Committees on Health Ethics for Southern Denmark, Denmark (S-20200031).The study is registered with (NCT04380909). Written, informed consent to participate will be obtained from all participants.The investigator will ensure that the study will be conducted in accordance with the protocol and applicable legislation (including the Danish Data Protection Act (DDPA) []) and that requirements issued by public authorities (the regional Data Protection Agency and the Danish the Committee on Health Research Ethics) have been and shall be followed.
: See Additional files , .
: MTS and KEA have received a grant from the LEO Foundation to conduct the trial. SRF is a speaker for Janssen and Taro; a consultant and speaker for Galderma, Stiefel/GlaxoSmithKline, Abbott Labs, LEO Pharma Inc.; has received grants from Galderma, Janssen, Abbott Labs, Amgen, Stiefel/GlaxoSmithKline, Celgene and Anacor; is a consultant for Amgen, Baxter, Caremark, Gerson Lehrman Group, Guidepoint Global, Hanall Pharmaceutical Co Ltd, Kikaku, Lilly, Merck & Co Inc., Merz Pharmaceuticals, Mylan, Novartis Pharmaceuticals, Pfizer Inc., Qurient, Suncare Research and Xenoport; is on an advisory board for Pfizer Inc.; is the founder of and holds stocks in Causa Research and holds stocks in and is majority owner of Medical Quality Enhancement Corporation; he receives royalties from UpToDate and Xlibris. SM and LPK declare no competing interests.