The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.
- Registration Number
- NCT05696392
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 47
- 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 โฅ 2 at the screening and baseline visits.
- Has an Itch NRS score โฅ 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group: Ruxolitinib ruxolitinib cream ruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film.
- Primary Outcome Measures
Name Time Method Change from baseline in Total Sleep Time (TST) Week 8 Total sleep time (TST) is the total amount of time spent during a planned sleep episode. TST will be measured by the ลura Ring wearable device.
- Secondary Outcome Measures
Name Time Method Change from baseline in PROMIS Sleep Disturbance Week 8 PROMIS sleep disturbance will be measured by a questionnaire which includes a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance.
Trial Locations
- Locations (30)
First Oc Dermatology
๐บ๐ธFountain Valley, California, United States
Ark Clinical Research
๐บ๐ธLong Beach, California, United States
Gw Training Center
๐บ๐ธWashington, District of Columbia, United States
Skin Care Research, Llc
๐บ๐ธBoca Raton, Florida, United States
Driven Research Llc
๐บ๐ธCoral Gables, Florida, United States
University of Florida Health Dermatology-Springhill
๐บ๐ธGainesville, Florida, United States
Skin Care Research, Llc Scr Hollywood
๐บ๐ธHollywood, Florida, United States
Ciocca Dermatology Pa
๐บ๐ธMiami, Florida, United States
Trueblue Clinical Research
๐บ๐ธTampa, Florida, United States
Dermatology Specialists Research Indiana
๐บ๐ธClarksville, Indiana, United States
Dawes Fretzin Clinical Research Group Llc
๐บ๐ธIndianapolis, Indiana, United States
Skin Sciences Pllc
๐บ๐ธLouisville, Kentucky, United States
Beth Israel Deaconess Medical Center (Bidmc)
๐บ๐ธBoston, Massachusetts, United States
Northeast Dermatology Associates
๐บ๐ธMethuen, Massachusetts, United States
Essential Dermatology
๐บ๐ธNatick, Massachusetts, United States
Washington University School of Medicine Dermatology
๐บ๐ธSaint Louis, Missouri, United States
Suny Downstate Health Sciences University
๐บ๐ธBrooklyn, New York, United States
Empire Dermatology
๐บ๐ธEast Syracuse, New York, United States
Sadick Dermatology
๐บ๐ธNew York, New York, United States
Skin Search of Rochester
๐บ๐ธRochester, New York, United States
Ohio Pediatric Research Association
๐บ๐ธDayton, Ohio, United States
Oregon Dermatology and Research Center
๐บ๐ธPortland, Oregon, United States
Knight Cancer Institute At Oregon Health and Science University
๐บ๐ธPortland, Oregon, United States
University of Pittsburgh
๐บ๐ธPittsburgh, Pennsylvania, United States
Clinical Research Center of the Carolinas
๐บ๐ธCharleston, South Carolina, United States
Arlington Research Center
๐บ๐ธArlington, Texas, United States
Jordan Valley Dermatology Center
๐บ๐ธSouth Jordan, Utah, United States
Pi Coor Clinical Research Llc
๐บ๐ธBurke, Virginia, United States
Clinical Research Partners Llc
๐บ๐ธRichmond, Virginia, United States
Dermatology Specialists of Spokane
๐บ๐ธSpokane, Washington, United States