Opzelura Experience Study

Atopic dermatitis is a common multifactorial skin disease. Topicals are the mainstay of treatment, but adherence to topicals is often abysmal, possibly worsened by the complexity of recommended treatment algorithms. Giving patients a simple, one drug approach may be advantageous.

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: ruxolitinib; Drug: ruxolitinib and an Eczema Action Plan

Detailed Description

Patients' adherence to even one topical treatment is often poor. Even giving patients two treatments reduces treatment adherence compared to one treatment alone. Complicating the treatment with numerous medications along with lifestyle changes may be overwhelming and counterproductive to patients' outcomes. The availability of topical ruxolitinib (Opzelura) provides an opportunity to give patients a highly effective treatment that, unlike standard topical steroids of variable potency, can be used on all areas, even on the face and body folds, and without long-term adverse outcomes. In theory, this offers an opportunity to improve atopic dermatitis (AD) outcomes by simplifying patients' treatment.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Irma Richardson, MHA; Phone Number: 336-716-2903; Email: irma.richardson@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
      • Contact: Irma Richardson, MHA; Phone Number: 336-716-2903; Email: irma.richardson@advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients ≥2 years of age
• Patients with a current diagnosis of atopic dermatitis that is mild-to-moderate in severity and in ≥2 body areas
• Patients with up to 20% total body surface area involvement
• Women of childbearing age taking/using a contraceptive

Exclusion Criteria:

• Patients without a current diagnosis of atopic dermatitis
• Patients who are prescribed changing systemic medications or treatments (phototherapy, biologics) for atopic dermatitis
• Patients who would require use of other topical medications for other diagnoses (tretinoin, clindamycin)
• Patients with areas of skin with active infection
• Patients who are pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: topical ruxolitinib (Opzelura); patients are directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed.	Drug: ruxolitinib; patients are directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed; Other Names: Opzelura
Active Comparator: topical ruxolitinib (Opzelura) and Complex Regimen; patients will be directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed. Patients will also be provided an Eczema Action Plan (EAP) with recommended lifestyle recommendations, including what cleanser to use, allergen avoidance, use of moisturizers, and bathing practices as determined by disease severity.	Drug: ruxolitinib and an Eczema Action Plan; patients will be directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed. Patients will also be provided an Eczema Action Plan (EAP) with recommended lifestyle recommendations, including what cleanser to use, allergen avoidance, use of moisturizers, and bathing practices as determined by disease severity; Other Names: Opzelura

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence percentage	Percentage of expected study medication applications completed during the 8-week treatment period, based on study-collected medication-use data.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adult Dermatology Life Quality Index (DQLI) scores	Total scores range from 0 to 30. The higher the score, the more significantly the skin disease impairs the patient's quality of life	Weeks 4 and 8
Children's Dermatology Life Quality Index (CDLQI) scores	The total score ranges from 0 to 30. Higher scores indicate a greater impairment in the child's quality of life	Weeks 4 and 8
Patient Oriented Eczema Measure (POEM) scores	The maximum total score is 28 - Higher scores indicate more severe eczema	Weeks 4 and 8
Patient Satisfaction Survey scores	responses to each Patient Satisfaction Survey question will be analyzed separately. Mean scores for the 1-10 questions will be compared between treatment arms.	Weeks 4 and 8
2-point Patient Global Assessment scores	A patient-reported outcome (PRO) used to gauge overall disease severity and response to treatment. The Patient Global Assessment is a binary outcome, happy/satisfied versus unhappy/unsatisfied, and will be assessed ats 4 and Weeks 4 and 8.	Weeks 4 and 8
Eczema Area and Severity Index (EASI) scores	Scores range from 0-72 - Higher scores indicate more severe eczema - The Eczema Area and Severity Index (EASI) is a standard clinical tool that measures the extent and severity of atopic dermatitis (eczema). It calculates a total score ranging from 0 (clear skin) to 72 (maximum severity), helping doctors track disease progression and treatment effectiveness over time.	Weeks 4 and 8
Percentage Change in Body Surface Area	Percentage Change in Body Surface Area affected	Weeks 4 and 8
Treatment-blinded Investigator Global Assessment (IGA) scores	a clinical trial metric where a physician assesses a patient's disease severity (often for skin conditions like atopic dermatitis or psoriasis) without knowing which intervention the patient received. This eliminates observer bias, ensuring objective, standardized evaluations. Scores range from 0-4 Higher scores indicate more severe dermatitis	Weeks 4 and 8
Investigator Likert scale assessment scores	Describes the investigator's response to the statement, "I feel this patient needs to be prescribed a systemic treatment," using a five-point scale from strongly disagree to strongly agree.	Baseline, Week 4, and Week 8
Adherence percentage	Percentage of expected study medication applications completed during the 8-week treatment period, based on study-collected medication-use data.	Day 3
Adherence percentage	Percentage of expected study medication applications completed during the 8-week treatment period, based on study-collected medication-use data.	Day 7

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Steven R Feldman, MD, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: treatment adherence; skin atrophy; topical medications
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Skin and Connective Tissue Diseases; Health Behavior; Dermatitis, Atopic; Treatment Adherence and Compliance; ruxolitinib
• Other Study ID Numbers: IRB000Opzelura

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No