Previous studies have evaluated the effectiveness of phosphodiesterase type 4 (PDE-4) inhibitors in the treatment of psoriasis. This study aims to assess the efficacy of Roflumilast (cream containing PDE-4 inhibitor) for the treatment of psoriasis.
This is a randomized, double-blind clinical trial, including a total of 331 participants diagnosed with plaque psoriasis. The participants were divided into three (1:1:1) groups and were assigned 0.3 roflumilast, 0.15% roflumilast, and vehicle cream (placebo) once a day for 12 weeks. 109 participants with roflumilast 0.3%, 113 with roflumilast 0.15%, and 109 with a placebo. The primary outcome was clear or almost clear skin, according to the IGA score.
After six weeks, clear or almost clear skin was reported in 28% of the participants who received 0.3% roflumilast, 23% in those who received 0.15% roflumilast 73% of patients in the roflumilast 0.3% group achieved a positive IGA score, followed by 44% of those in the roflumilast 0.15% group, and 29% in the vehicle group.
Roflumilast cream, when used once daily on the affected areas of psoriasis, showed superior results compared to vehicle cream (placebo). The research also concluded that higher concentrations of PDE-4 were positively associated with an improvement in the IGA score.