The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance. (MORPHEUS)
Atopic Dermatitis
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring ruoltitinib, atopic dermatitis, sleep distubance, itch, Opzelura
Eligibility Criteria
Inclusion Criteria: Has clinically confirmed diagnosis of active AD according to Hanifin and Rajka (1980) criteria. Has at least a 2-year history of AD (information obtained from medical chart, participant's physician, or directly from the participant). Has an overall BSA affected by AD of 3%-20% (excluding scalp) at the screening and baseline visits. Has an IGA score ≥ 2 at the screening and baseline visits. Has an Itch NRS score ≥ 4 at the screening and baseline visits. Willing to complete the once-daily Itch NRS (24-hour recall period) entries at approximately the same time each day during the study. Agrees to maintain a regular sleep schedule during the study period. Willing and able to follow required study procedures for measuring sleep for the duration of the study. Exclusion Criteria: Currently using a wearable or other device for monitoring sleep patterns and unwilling to discontinue its use during the study. Currently has a schedule that includes nighttime work shifts. Has had significant flares or unstable course in AD (ie, condition worsened significantly or required significant change in medications, as per medical judgment) in the previous 4 weeks before screening (information obtained from medical chart, participant's physician, or directly from the participant). Has received any ultraviolet B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to the screening period. Has had psoralen plus ultraviolet A treatment within 4 weeks prior to the screening period. Has received a nonbiological investigational product or device within 4 weeks prior to the screening period, or is currently enrolled in another investigational drug study. Has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the screening period. Has had prior treatment with a JAK inhibitor that was discontinued for safety reasons or tolerance problems. Has a known or suspected allergy to ruxolitinib or any component of the study drug.
Sites / Locations
- First Oc DermatologyRecruiting
- Ark Clinical ResearchRecruiting
- The Gw Medical Faculty AssociatesRecruiting
- Skin Care Research, LlcRecruiting
- Trueblue Clinical ResearchRecruiting
- Driven Research LlcRecruiting
- University of Florida Health Dermatology-SpringhillRecruiting
- Skin Care Research, Llc Scr HollywoodRecruiting
- Ciocca Dermatology PaRecruiting
- Dermatology Specialists Research IndianaRecruiting
- Dawes Fretzin Clinical Research Group LlcRecruiting
- Skin Sciences PllcRecruiting
- Northeast Dermatology AssociatesRecruiting
- Beth Israel Deaconess Medical Center (Bidmc)Recruiting
- Essential DermatologyRecruiting
- Washington University School of Medicine DermatologyRecruiting
- Suny Downstate Health Sciences UniversityRecruiting
- Empire DermatologyRecruiting
- Sadick DermatologyRecruiting
- Skin Search of RochesterRecruiting
- Ohio Pediatric Research AssociationRecruiting
- Oregon Dermatology and Research CenterRecruiting
- Knight Cancer Institute At Oregon Health and Science UniversityRecruiting
- University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical BuildingRecruiting
- Clinical Research Center of the CarolinasRecruiting
- Arlington Research CenterRecruiting
- Jordan Valley Dermatology CenterRecruiting
- Pi Coor Clinical Research Llc
- Clinical Research Partners Llc
- Dermatology Specialists of SpokaneRecruiting
Arms of the Study
Arm 1
Experimental
Treatment Group: Ruxolitinib
ruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film.