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 ≥ 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.
- 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 Ōura 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
🇺🇸Fountain Valley, California, United States
Ark Clinical Research
🇺🇸Long Beach, California, United States
Gw Training Center
🇺🇸Washington, District of Columbia, United States
Skin Care Research, Llc
🇺🇸Boca Raton, Florida, United States
Driven Research Llc
🇺🇸Coral Gables, Florida, United States
University of Florida Health Dermatology-Springhill
🇺🇸Gainesville, Florida, United States
Skin Care Research, Llc Scr Hollywood
🇺🇸Hollywood, Florida, United States
Ciocca Dermatology Pa
🇺🇸Miami, Florida, United States
Trueblue Clinical Research
🇺🇸Tampa, Florida, United States
Dermatology Specialists Research Indiana
🇺🇸Clarksville, Indiana, United States
Scroll for more (20 remaining)First Oc Dermatology🇺🇸Fountain Valley, California, United States