The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.

Stopped early · Phase 4

Conditions studied: Atopic Dermatitis

In brief

The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis.

Key facts

Study ID

NCT05696392

Run by

Incyte Corporation

People needed

47

Starts

2023-03-16

Expected to finish

2025-01-22

Last updated by the study team

2025-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• First Oc Dermatology — Fountain Valley, California, United States
• Ark Clinical Research — Long Beach, California, United States
• Gw Training Center — Washington D.C., 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
• Dawes Fretzin Clinical Research Group Llc — Indianapolis, Indiana, United States
• Skin Sciences Pllc — Louisville, Kentucky, United States
• Beth Israel Deaconess Medical Center (Bidmc) — Boston, Massachusetts, United States
• Northeast Dermatology Associates — Methuen, Massachusetts, United States
• Essential Dermatology — Natick, Massachusetts, United States
• Washington University School of Medicine Dermatology — St Louis, Missouri, United States
• Suny Downstate Health Sciences University — Brooklyn, New York, United States
• Empire Dermatology — East Syracuse, New York, United States
• Sadick Dermatology — New York, New York, United States
• Skin Search of Rochester — Rochester, New York, United States
• Ohio Pediatric Research Association — Dayton, Ohio, United States
• Oregon Dermatology and Research Center — Portland, Oregon, United States
• Knight Cancer Institute At Oregon Health and Science University — Portland, Oregon, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Clinical Research Center of the Carolinas — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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