Arcutis Reports Completion of Patient Enrollment for Roflumilast in P-III (STRATUM) Trial for the Treatment of Seborrheic Dermatitis
Shots:
- The company has completed enrollment of the P-III (STRATUM) trial to evaluate the safety, tolerability, and efficacy of roflumilast (0.3% foam, qd) in 457 patients aged ≥9yrs. with moderate to severe seborrheic dermatitis
- The 1EPs of the study is the proportion of patients who achieved an IGA score of “clear” or “almost clear” along with a 2-point improvement @8wks. The results are expected in mid-2022
- The company is planning to submit an NDA in the US in H1’23. Roflumilast is a topical formulation of a highly potent and selective PDE4 inhibitor & has the potential to treat hair-bearing areas of the body including the face
Ref: Globe Newswire | Image: Arcutis
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