PF-07038124 vs roflumilast

NCT05375955 · Phase 2 · completed

This was a randomized, quadruple-blind, vehicle-controlled Phase 2 trial with a hard clinical primary endpoint (IGA/PGA response at week 12) and an adequate sample size (263 participants). However, the primary comparison was only partly successful: in atopic dermatitis, neither PF-07038124 0.01% (23.8% vs 11.4%, p=0.0711) nor 0.03% (21.4% vs 11.4%, p=0.1290) reached statistical significance, while in plaque psoriasis the 0.03% (37.1% vs 8.8%, p=0.0028) and 0.06% (45.5% vs 8.8%, p=0.0003) doses did. Because the primary endpoint was split across two diseases and only one cohort met it, the overall result is mixed rather than a clean success, capping the evidence at moderate.

NCT06648772 · Phase 3 · completed

The study randomly assigned 190 participants to roflumilast cream or vehicle cream and used quadruple blinding of participants, care providers, investigators, and outcome assessors. Its primary endpoint was a clinical psoriasis severity measure, but whether that endpoint was met cannot be determined because results are not available.