Dermavant Sciences has reported positive results from a phase 4 trial of its plaque psoriasis-approved Vtama (tapinarof) cream 1% in plaque psoriasis affecting the head and neck region.
Approximately 125 million people worldwide are affected by some form of psoriasis, a chronic inflammatory condition caused by dysfunction of the immune system, which results in skin cells reproducing at a faster rate than normal.
Up to 90% of patients with psoriasis have plaque psoriasis, characterised by dry, raised, red skin lesions (plaques) covered with silvery scales. The plaques may be itchy or painful and can occur anywhere on the body.
The open-label DMVT-505-4002 study enrolled 31 adults with mild, moderate and severe head and neck plaque psoriasis at eight sites across the US.
Results showed that 88.5% of patients achieved a target lesion Physician Global Assessment (tPGA) success score of zero (clear) or one (almost clear) and a two-point or greater improvement in tPGA score from baseline at week 12, meeting the study’s primary endpoint.
The secondary endpoint of the study was also met, with tPGA success achieved as early as week one in some patients and at a median time of approximately four weeks.
Dermavant’s chief medical officer, Philip Brown, said: “In this phase 4 trial, a majority of the adult patients suffered from scalp psoriasis, making the outcomes from this trial significant, as they further reinforce the efficacy, safety, tolerability and cosmetic elegance of Vtama cream even when used in hair bearing areas such as the head and neck region.”
The results build on the body of data for Vtama cream in adult plaque psoriasis. In the phase 3 PSOARING 1 and 2 studies, Vtama cream demonstrated a Physician Global Assessment success rate of 36% and 40%, respectively, for adults with plaque psoriasis versus 6% for those receiving vehicle at week 12.
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