Opzelura Experience Study

NCT07661979 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB00152892
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

skin atrophy; treatment adherence; topical medications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Adult Dermatology Life Quality Index (DQLI) scores

  Weeks 4 and 8

• Children's Dermatology Life Quality Index (CDLQI) scores

  Weeks 4 and 8

• Patient Oriented Eczema Measure (POEM) scores

  Weeks 4 and 8

• Patient Satisfaction Survey scores

  Weeks 4 and 8

• 2-point Patient Global Assessment scores

  Weeks 4 and 8

Study Arms (2)

topical ruxolitinib (Opzelura)

EXPERIMENTAL

patients are directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed.

Drug: ruxolitinib

topical ruxolitinib (Opzelura) and Complex Regimen

ACTIVE COMPARATOR

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

Interventions

ruxolitinib DRUG

patients are directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed

Also known as: Opzelura

topical ruxolitinib (Opzelura)

ruxolitinib and an Eczema Action Plan DRUG

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

Also known as: Opzelura

topical ruxolitinib (Opzelura) and Complex Regimen

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Treatment Adherence and Compliance

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Health Behavior; Behavior

Study Officials

• Steven R Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irma Richardson, MHA

CONTACT

336-716-2903; irma.richardson@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator assessing the clinical photographs will be blinded to treatment assignment. Participants will know whether they received the Eczema Action Plan
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicenter, prospective, randomized parallel-arm study over 8 weeks. Participants will be randomized at baseline to one of two treatment arms. In Arm 1, patients are directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed. In Arm 2, 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.

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)