Atopic DermatitisPhase 4NCT07661979
Opzelura Experience Study
A Phase 4 study testing ruxolitinib and ruxolitinib and an Eczema Action Plan in people with Atopic Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- ruxolitinib and ruxolitinib and an Eczema Action Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Irma Richardson, MHA, 336-716-2903, irma.richardson@advocatehealth.org
About this 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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- ruxolitinib, ruxolitinib and an Eczema Action Plan
- Keywords
- skin atrophy, treatment adherence, topical medications
- Medical subject headings
- Dermatitis, Atopic, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ruxolitinibDrug
Also called Opzelura
patients are directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed
ruxolitinib and an Eczema Action PlanDrug
Also called Opzelura
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 group | Role | What they receive |
|---|---|---|
| topical ruxolitinib (Opzelura) | Experimental | patients are directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed. Receives: 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. Receives: Drug: ruxolitinib and an Eczema Action Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence percentage
Percentage of expected study medication applications completed during the 8-week treatment period, based on study-collected medication-use data.
Measured: Week 8
Secondary outcomes (11)
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
Measured: 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
Measured: Weeks 4 and 8
Patient Oriented Eczema Measure (POEM) scores
The maximum total score is 28 - Higher scores indicate more severe eczema
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 4 and 8
Percentage Change in Body Surface Area
Percentage Change in Body Surface Area affected
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day 3
Adherence percentage
Percentage of expected study medication applications completed during the 8-week treatment period, based on study-collected medication-use data.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661979
- Sponsor's protocol ID
- IRB00152892
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opzelura Experience Study
- ClinicalTrials.gov ID
- NCT07661979
- Acronym / sponsor ID
- IRB00152892
- Conditions
- Atopic Dermatitis
- Keywords
- skin atrophy, treatment adherence, topical medications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| topical ruxolitinib (Opzelura) | Experimental | Drug: ruxolitinibpatients are directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed. |
| topical ruxolitinib (Opzelura) and Complex Regimen | Active comparator | Drug: ruxolitinib and an Eczema Action Planpatients 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ruxolitinibAlso: Opzelurapatients are directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed | Drug | topical ruxolitinib (Opzelura) |
| ruxolitinib and an Eczema Action PlanAlso: Opzelurapatients 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 | topical ruxolitinib (Opzelura) and Complex Regimen |
Primary outcome
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven R Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ruxolitinib and ruxolitinib and an Eczema Action Plan in people with Atopic Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irma Richardson, MHA (336-716-2903, irma.richardson@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence percentage (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.