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Not yet recruiting NCT07661979

Opzelura Experience Study

Phase IV Interventional Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ruxolitinib, ruxolitinib and an Eczema Action Plan.
Who it may be relevant to
Registry conditions: Atopic Dermatitis. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Adherence percentage [Time frame: Week 8]
Secondary outcome measures (11)
  • Adult Dermatology Life Quality Index (DQLI) scores [Time frame: Weeks 4 and 8]
  • Children's Dermatology Life Quality Index (CDLQI) scores [Time frame: Weeks 4 and 8]
  • Patient Oriented Eczema Measure (POEM) scores [Time frame: Weeks 4 and 8]
  • Patient Satisfaction Survey scores [Time frame: Weeks 4 and 8]
  • 2-point Patient Global Assessment scores [Time frame: Weeks 4 and 8]
  • Eczema Area and Severity Index (EASI) scores [Time frame: Weeks 4 and 8]
  • Percentage Change in Body Surface Area [Time frame: Weeks 4 and 8]
  • Treatment-blinded Investigator Global Assessment (IGA) scores [Time frame: Weeks 4 and 8]
  • Investigator Likert scale assessment scores [Time frame: Baseline, Week 4, and Week 8]
  • Adherence percentage [Time frame: Day 3]
  • Adherence percentage [Time frame: Day 7]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT07661979 · IRB00152892

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗