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Opzelura Experience Study

3 september 2026 uppdaterad av: Wake Forest University Health Sciences
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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: topical ruxolitinib (Opzelura)
patients are directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed.
Läkemedel: ruxolitinib
patients are directed to apply topical ruxolitinib (Opzelura) twice daily to all affected areas until clear, then as needed
Andra namn:
  • Opzelura
Aktiv komparator: topical ruxolitinib (Opzelura) and Complex Regimen
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.
Läkemedel: 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
Andra namn:
  • Opzelura

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adherence percentage
Tidsram: Week 8
Percentage of expected study medication applications completed during the 8-week treatment period, based on study-collected medication-use data.
Week 8

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adult Dermatology Life Quality Index (DQLI) scores
Tidsram: 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
Weeks 4 and 8
Children's Dermatology Life Quality Index (CDLQI) scores
Tidsram: 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
Weeks 4 and 8
Patient Oriented Eczema Measure (POEM) scores
Tidsram: Weeks 4 and 8
The maximum total score is 28 - Higher scores indicate more severe eczema
Weeks 4 and 8
Patient Satisfaction Survey scores
Tidsram: 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.
Weeks 4 and 8
2-point Patient Global Assessment scores
Tidsram: 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.
Weeks 4 and 8
Eczema Area and Severity Index (EASI) scores
Tidsram: 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.
Weeks 4 and 8
Percentage Change in Body Surface Area
Tidsram: Weeks 4 and 8
Percentage Change in Body Surface Area affected
Weeks 4 and 8
Treatment-blinded Investigator Global Assessment (IGA) scores
Tidsram: 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
Weeks 4 and 8
Investigator Likert scale assessment scores
Tidsram: 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.
Baseline, Week 4, and Week 8
Adherence percentage
Tidsram: Day 3
Percentage of expected study medication applications completed during the 8-week treatment period, based on study-collected medication-use data.
Day 3
Adherence percentage
Tidsram: Day 7
Percentage of expected study medication applications completed during the 8-week treatment period, based on study-collected medication-use data.
Day 7

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Wake Forest University Health Sciences

Utredare

  • Huvudutredare: Steven R Feldman, MD, PhD, Wake Forest University Health Sciences

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 december 2026

Primärt slutförande (Beräknad)

1 augusti 2027

Avslutad studie (Beräknad)

1 oktober 2027

Studieregistreringsdatum

Först inskickad

17 juni 2026

Först inskickad som uppfyllde QC-kriterierna

17 juni 2026

Första postat (Faktisk)

23 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB00152892

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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