Health TrialsbyHealthPanel

Opzelura Experience Study

ConditionAtopic Dermatitis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ruxolitinib

    Drug

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

  • 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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: topical ruxolitinib (Opzelura)Experimental treatment 1 intervention
Group B: topical ruxolitinib (Opzelura) and Complex RegimenActive comparator 1 intervention

Trial outcomes

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.

Time frame
Week 8

Secondary outcomes

1

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

Time frame
Weeks 4 and 8
2

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

Time frame
Weeks 4 and 8
3

Patient Oriented Eczema Measure (POEM) scores

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

Time frame
Weeks 4 and 8
4

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.

Time frame
Weeks 4 and 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: