Phase III STRATUM study results positive for roflumilast foam for treatment of seborrheic dermatitis.
Arcutis Inc., has announced topline data from the Phase III STRATUM study of 457 seborrheic dermatitis patients. Roflumilast foam 0.3% met the primary endpoint with 80.1% of treated participants achieving investigator’s global assessment scale (IGA) success at eight weeks versus 59.2% of vehicle control patients (p<0.0001).
iga success was defined as a score of clear or almost clear plus at least a two-grade improvement from baseline.
Over half of roflumilast foam patients achieved an IGA score of clear at eight weeks and roflumilast showed significant improvement in secondary measures such as itching, scaling and redness. The improvement in itch is important given the key role of the symptom in patients’ quality of life, No treatment-related adverse events were reported.
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