Study protocol for testing pharmacological conditioning as a drug dose reduction strategy in patients with psoriasis in a randomised controlled trial.

Abstract

Psoriasis is a chronic inflammatory skin disease that significantly impacts patients' quality of life. Although biological therapies are effective, they are associated with high costs and potential side effects, necessitating strategies for dose reduction. Pharmacological conditioning, using placebo mechanisms through associative learning, presents a promising approach to maintain therapeutic efficacy with lower doses of medication. The single-centre, randomised controlled trial aims to investigate pharmacological conditioning with secukinumab in patients with moderate-to-severe psoriasis (N=168). Participants will be randomly allocated to a treatment-as-usual group or one of two experimental groups receiving partial or continuous reinforcement schedules with reduced secukinumab doses combined with a distinctive gustatory stimulus. Primary outcomes include changes in itch intensity, skin-related quality of life and objective disease severity. Secondary outcomes encompass psychological variables, side effects and biological markers. Results may contribute to optimised long-term psoriasis management, reducing medication burden while maintaining treatment efficacy. The study protocol was approved by the ethics committee of the University Hospital Essen (19-8636 BO) on 20 November 2023. Written informed consent will be obtained from all participants. Participant confidentiality will be ensured through pseudonymised data handling and secure storage. The results will be disseminated through peer-reviewed publications. DRKS00034977.