This study is being done to obtain descriptive classifications of pruritus using a patient directed survey system and assess change in pruritus over time in patients with Atopic Dermatitis over 4 weeks with use of topical Roflumilast cream 0.15% QD.
Male or female subjects aged 12 years or older
Participants and/or legal guardians are legally competent to sign and give informed consent.
Clinically confirmed diagnosis of active mild to moderate AD according to Hanifin and Rajka criteria (1980).
History of AD for at least 6 months as determined by the Investigator using information from the subject's medical chart, from the subject's physician, or through subject/caregiver interview. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening
Subjects with any medical condition or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments.
Participant had significant flares or unstable course in AD (i.e., condition worsened significantly or required significant change in medications, as per medical judgment) in the previous 4 weeks before screening or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.
Participant has significant active systemic or localized infection, like clinically infected AD, or has used antibiotics (systemic or topical), antifungal or antiviral agents within 2 weeks prior to the run-in period.
Single group
Roflumilast Cream 0.15%
Drugtopically applied to the affected areas once daily
Number of descriptors (besides itch) used to describe skin sensations associated with AD
Participants will download and install the ExpiWell app. Descriptive classification of itch will be captured in the app. The number of descriptions selected by the participant will be tabulated to assess if there is more than just a description of itch for their skin sensation.
Change from baseline in modified Itch Numeric Rating Scale (mItch-NRS) on first day of application.
Change from baseline in mItch-NRS at 5, 10, 15, 20, 25, 30, 45, 60, 90, and 120 minutes, and 4, 6, and 8 hours
Change from baseline in Worst Itch Numeric Rating Scale (WI-NRS) at 4 weeks
Change in the Worst Itch Numeric Rating Scale (WI-NRS) response from baseline to week 4
Change from baseline in Dermatology Life Quality Index (DLQI)
Change from baseline in DLQI at week 2 and week 4
Change from baseline in Validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD)
Change from baseline in vIGA-AD at week 2 and week 4
Change from baseline in Treatment Satisfaction Questionnaire (TSQ) outcomes
Change from baseline in TSQ outcomes at week 2 and week 4
Impact assessment question outcome trends
Assessing Impact assessment question outcomes at baseline and week 4
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Integrative Skin Science and Research
Lead sponsor
Arcutis Biotherapeutics, Inc.
Collaborator
