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Article History

Received: 30 May 2025

Accepted: 8 July 2025

First Online: 17 July 2025

Declarations

:

: Dr. Roger Imboden is a paid employee of Drossapharm AG, Arlesheim, Switzerland (the study Sponsor). Prof. Hans-Georg Predel and Dr. Bruno Giannetti received payment from Drossapharm AG, Arlesheim, Switzerland for their respective involvement in the study. Both authors have received payment from other Sponsors for their participation in similar studies of other topical NSAID formulations. Ralph-Steven Wedemeyer is a paid employee of SocraTec R&D GmbH, Oberursel, Germany, which received payment from Drossapharm AG, Arlesheim, Switzerland for conducting the data management, statistical analysis and reporting of the study. Dr. Andrew Leary is a paid employee of regenold GmbH, Badenweiler, Germany, which received payment from Drossapharm AG, Arlesheim, Switzerland for clinical and regulatory consultancy services.

: The clinical trial was designed, implemented and reported in accordance with the ICH Guidelines for Good Clinical Practice, with applicable local regulations, and with the ethical principles laid down in the Declaration of Helsinki. Ethical approval for the study was granted by the Ethics Committee of the Landesärztekammer Nordrhein (three centres; ref. 2021376) and by the Ethics Committee of the Bayerischen Landesärztekammer (one centre). All patients provided written (signed) informed consent prior to participation in the study. The consent document informed patients that any scientific publication of results would be made in a form that does not allow any direct conclusions to be drawn about their person.