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NCT Number: NCT07661979

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.

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Key information

Conditions

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

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location contact

Irma Richardson, MHA

CONTACT

[email protected]

336-716-2903

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ruxolitinib

Drug

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

Other names: 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

Other names: Opzelura

Primary outcomes

  1. Adherence percentage

    Time frame: Week 8

    Percentage of expected study medication applications completed during the 8-week treatment period, based on study-collected medication-use data.

Secondary outcomes

  1. Adult Dermatology Life Quality Index (DQLI) scores

    Time frame: Weeks 4 and 8

    Total scores range from 0 to 30. The higher the score, the more significantly the skin disease impairs the patient's quality of life

  2. Children's Dermatology Life Quality Index (CDLQI) scores

    Time frame: Weeks 4 and 8

    The total score ranges from 0 to 30. Higher scores indicate a greater impairment in the child's quality of life

  3. Patient Oriented Eczema Measure (POEM) scores

    Time frame: Weeks 4 and 8

    The maximum total score is 28 - Higher scores indicate more severe eczema

  4. Patient Satisfaction Survey scores

    Time frame: Weeks 4 and 8

    responses to each Patient Satisfaction Survey question will be analyzed separately. Mean scores for the 1-10 questions will be compared between treatment arms.

  5. 2-point Patient Global Assessment scores

    Time frame: Weeks 4 and 8

    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.

  6. Eczema Area and Severity Index (EASI) scores

    Time frame: Weeks 4 and 8

    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.

  7. Percentage Change in Body Surface Area

    Time frame: Weeks 4 and 8

    Percentage Change in Body Surface Area affected

  8. Treatment-blinded Investigator Global Assessment (IGA) scores

    Time frame: Weeks 4 and 8

    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

  9. Investigator Likert scale assessment scores

    Time frame: Baseline, Week 4, and Week 8

    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.

  10. Adherence percentage

    Time frame: Day 3

    Percentage of expected study medication applications completed during the 8-week treatment period, based on study-collected medication-use data.

  11. Adherence percentage

    Time frame: Day 7

    Percentage of expected study medication applications completed during the 8-week treatment period, based on study-collected medication-use data.

Study contacts

Contact information is provided by the study sponsor or research team.

Irma Richardson, MHA

CONTACT

[email protected]

336-716-2903

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 23, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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