Atopic Dermatitis
Conditions
Keywords
skin atrophy, treatment adherence, topical medications
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.
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
DRUGruxolitinib
patients are directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed
DRUGruxolitinib 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
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The investigator assessing the clinical photographs will be blinded to treatment assignment. Participants will know whether they received the Eczema Action Plan
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence percentage | Week 8 | Percentage of expected study medication applications completed during the 8-week treatment period, based on study-collected medication-use data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adult Dermatology Life Quality Index (DQLI) scores | 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 |
| Children's Dermatology Life Quality Index (CDLQI) scores | 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 |
| Patient Oriented Eczema Measure (POEM) scores | Weeks 4 and 8 | The maximum total score is 28 - Higher scores indicate more severe eczema |
| Patient Satisfaction Survey scores | 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. |
| 2-point Patient Global Assessment scores | 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. |
| Eczema Area and Severity Index (EASI) scores | 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. |
| Percentage Change in Body Surface Area | Weeks 4 and 8 | Percentage Change in Body Surface Area affected |
| Treatment-blinded Investigator Global Assessment (IGA) scores | 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 |
| Investigator Likert scale assessment scores | 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. |
| Adherence percentage | Day 3 | Percentage of expected study medication applications completed during the 8-week treatment period, based on study-collected medication-use data. |
Countries
United States
Contacts
CONTACTIrma Richardson, MHA
PRINCIPAL_INVESTIGATORSteven R Feldman, MD, PhD
Wake Forest University Health Sciences
Outcome results
None listed