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.
Parallel
Roflumilast Foam 0.3%
DrugRoflumilast foam 0.3% is applied once daily for 8 weeks.
Vehicle foam
DrugVehicle foam is applied once daily for 8 weeks.
Percentage of trial participants with IGA success at Week 8
The IGA is a static evaluation of qualitative overall seborrheic dermatitis severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). IGA success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement.
Percentage of trial participants with WI-NRS success in subjects with a Baseline WI-NRS pruritus score of ≥4
The WI-NRS is a simple, single item to assess the patient-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch"). WI-NRS success is defined as the achievement of a ≥4-point improvement from baseline in WI-NRS pruritus score.
Percentage of trial participants with IGA success at Week 2 and Week 4
The IGA is a static evaluation of qualitative overall seborrheic dermatitis severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). IGA success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement.
Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 at Week 8
Overall Assessment of Scaling are static qualitative evaluations, involving an ordinal scale with 4 severity grades (reported only in integers of 0 to 3). Each grade is defined by a distinct and clinically relevant morphologic description that minimizes inter-observer variability.
Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 at Week 8
Overall Assessment of Erythema is a static qualitative evaluation, involving an ordinal scale with 4 severity grades (reported only in integers of 0 to 3). Each grade is defined by a distinct and clinically relevant morphologic description that minimizes inter-observer variability.
Achievement of an Overall Assessment of Scaling score of 0 at Week 2 and Week 4
Overall Assessment of Scaling are static qualitative evaluations, involving an ordinal scale with 4 severity grades (reported only in integers of 0 to 3). Each grade is defined by a distinct and clinically relevant morphologic description that minimizes inter-observer variability.
Achievement of an Overall Assessment of Erythema score of 0 at Week 2 and Week 4
Overall Assessment of Erythema is a static qualitative evaluation, involving an ordinal scale with 4 severity grades (reported only in integers of 0 to 3). Each grade is defined by a distinct and clinically relevant morphologic description that minimizes inter-observer variability.
Absolute changes from baseline in Scalpdex score at Week 2, Week 4, and Week 8
The Scalpdex score is used to assess the severity of scalp disorders.
Absolute change from baseline in DLQI/CDLQI score at Week 2, Week 4, Week 8
The DLQI/CDLQI is a simple, self-administered and user-friendly validated questionnaire. The DLQI/CDLQI is designed to measure the health-related quality of life of patients suffering from a skin disease. The DLQI/CDLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI will be completed by participants ages 17 years and older. The CDLQI will be completed by caregivers of participants ages 9-16 years.
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Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Lead sponsor
Arcutis Biotherapeutics, Inc.
Collaborator
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