This study will assess the safety and efficacy of Roflumilast foam 0.3% (ZORYVE®) versus vehicle applied once a day for 8 weeks by trial participants with seborrheic dermatitis.
Males and females ages 9 years and older (inclusive) at the time of consent.
Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at screening as determined by the Investigator. Stable disease for the past 4 weeks.
Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.
An Investigator Global Assessment (IGA) disease severity of at least moderate ('3') at baseline.
Trial participants with any serious medical condition or clinically significant laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
Any conditions in the treatment area judged by the investigator at screening or baseline that may interfere with efficacy assessment (e.g., confirmed cutaneous bacterial, viral or parasitic infections, psoriasis, atopic dermatitis, acne, as well as pigmentation, extensive scars, pigmentary lesions, sunburn, etc.).
Trial participants with active pityriasis/tinea amiantacea.
Current or history of cancer within 5 years from Screening with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix.
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Lead sponsor
Arcutis Biotherapeutics, Inc.
Collaborator