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Ruxolitinib Cream Combined With Corticosteroids for Progressive Non-Segmental Vitiligo: A Multicenter Real-World Study

30. Juni 2026 aktualisiert von: ShanShan Li

Efficacy and Safety of Ruxolitinib Phosphate Cream Combined With Corticosteroids in Patients With Progressive Non-Segmental Vitiligo: A Multicenter Real-World Study

This study is a prospective, multicenter, real-world observational study to assess the clinical efficacy and safety of topical 1.5% Ruxolitinib phosphate cream used in combination with systemic corticosteroids in a real-world clinical setting. The study plans to observe patients aged 12 years and older with active, progressive non-segmental vitiligo involving the face. All treatments are prescribed based on standard routine clinical care and medical practice guidelines. Participants will apply Ruxolitinib cream twice daily to affected skin areas for up to 24 weeks alongside a standard corticosteroid regimen. The primary goal of the study is to evaluate how many patients achieve a 75% or greater improvement in their facial vitiligo patches after 12 weeks of combined treatment. Safety and side effects will also be closely monitored throughout the 24-week period.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This prospective, multicenter, real-world cohort study plans to enroll 300 patients with active, progressive non-segmental vitiligo. Following routine medical diagnosis and standard-of-care clinical decisions, patients will receive treatment combining topical 1.5% Ruxolitinib phosphate cream applied twice daily (maximum 2 tubes/200g per month) for up to 24 weeks with concurrent corticosteroid therapy. Corticosteroid regimens consist of either intramuscular Compound Betamethasone injection (1ml once monthly) or Dexamethasone oral low-dose pulse therapy (2.25mg single dose once daily on Saturdays and Sundays) for a maximum duration of 24 weeks.The sample size of 300 patients is mathematically powered to test a superiority hypothesis. While historical single-center real-world data for ruxolitinib cream monotherapy demonstrated a 12-week response rate of 24.7%, this study establishes a conservative historical target control threshold baseline (P0) of 24%. Assuming the real-world addition of corticosteroid pulse therapy achieves an improved true response rate (P1) of 32%, a sample size of 237 evaluable participants provides 80% statistical power (beta = 0.20) to reject the null hypothesis using a two-sided exact binomial test at a significance level of alpha = 0.05. Accounting for an expected 20% drop-out or loss-to-follow-up rate, the final enrollment target was set to 300 participants. Efficacy analyses for the primary endpoint at Week 12 will utilize Multiple Imputation methods to account for missing data under Missing at Random (MAR) assumptions.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

300

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
      • Changzhou, China
        • Changzhou First People's Hospital
        • Kontakt:
      • Dongying, China
        • Dongying People's Hospital
        • Kontakt:
      • Lianyungang, China
        • The First People's Hospital of Lianyungang
        • Kontakt:
      • Nanjing, China
        • Nanjing Drum Tower Hospital
        • Kontakt:
      • Nanjing, China
        • U-Family Clinic (Nanjing) Co., Ltd.
        • Kontakt:
      • Shanghai, China
        • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
      • Shenzhen, China
        • Shenzhen Hospital, Southern Medical University
        • Kontakt:
      • Suzhou, China
        • The First Affiliated Hospital of Soochow University
        • Kontakt:
    • Jiangsu
      • Huai'an, Jiangsu, China
        • The Second People's Hospital of Huai'an
        • Kontakt:
          • Chunsheng Yang
          • Telefonnummer: +86 18752409168
          • E-Mail: 8yung@sina.com
      • Suzhou, Jiangsu, China
        • The Fourth Affiliated Hospital of Soochow University
        • Kontakt:
      • Xuzhou, Jiangsu, China
        • Affiliated Hospital of Xuzhou Medical University
        • Kontakt:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • XinHua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Males and females aged 12 and older presenting with active, progressive non-segmental vitiligo with facial involvement and a total body surface area (BSA) depigmentation under 10%. Subjects are selected via a non-probability clinical recruitment strategy.

Beschreibung

Inclusion Criteria:

  • Age ≥ 12 years at the time of signing informed consent.
  • Clinical diagnosis of non-segmental vitiligo with facial involvement, and total body surface area (BSA) depigmentation ≤ 10%.
  • Diagnosed with progressive/active vitiligo meeting at least one of the following: Vitiligo Disease Activity (VIDA) score ≥ 3.

Clinical signs including trichrome vitiligo, confetti-like depigmentation, or Koebner phenomenon.

The extent of lesions under Wood's lamp is larger than that visible to the naked eye.

  • Agrees to have no pregnancy plans and uses effective contraception during the study and up to 4 weeks after the last dose.
  • Voluntarily signs the informed consent form and agrees to regular follow-up visits.

Exclusion Criteria:

  • Diagnosis of other clinical forms of vitiligo (e.g., segmental vitiligo).
  • Clinically diagnosed with stable vitiligo.
  • Co-existing skin depigmentation disorders affecting efficacy evaluation (e.g., pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive macular hypomelanosis, nevus anemicus, chemical leukoderma, tinea versicolor).
  • Leukoderma lesions with more than 1/3 white hair, or lesions accompanied by white hair where the investigator assesses the probability of benefit from participating is low based on clinical experience.
  • Contraindications to systemic corticosteroid use.
  • Known hypersensitivity or allergy to the study medications or excipients.
  • Known end-stage renal disease (ESRD) or currently undergoing renal replacement therapy (e.g., dialysis).
  • Concurrent participation in other clinical studies.
  • Any other condition which, in the investigator's judgment, makes the patient unsuitable for the study

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index 75 (F-VASI 75)
Zeitfenster: Week 12
The percentage of patients achieving a ≥ 75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI) score. F-VASI measures facial depigmentation using the Palmar method (1% Body Surface Area (BSA) corresponds to one hand surface area of the participant) across facial anatomical regions with a total score range of 0 to 3. Higher scores represent greater depigmentation. Missing primary endpoint data will be handled via Multiple Imputation based on Missing at Random (MAR) assumptions.
Week 12

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of Participants Achieving F-VASI 50 and F-VASI 90
Zeitfenster: Weeks 4, 8, 12, and 24
Percentage of participants achieving a ≥50% or ≥90% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI).
Weeks 4, 8, 12, and 24
Proportion of Participants Achieving F-VASI 75 at Remaining Timepoints
Zeitfenster: Weeks 4, 8, and 24
Percentage of participants achieving a ≥75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI).
Weeks 4, 8, and 24
Proportion of Participants Achieving T-VASI 50, T-VASI 75, and T-VASI 90
Zeitfenster: Weeks 4, 8, 12, and 24
Percentage of participants achieving a ≥50%, ≥75%, or ≥90% improvement from baseline in the Total Vitiligo Area Scoring Index (T-VASI).
Weeks 4, 8, 12, and 24
Change From Baseline in Vitiligo Disease Activity (VIDA) Score
Zeitfenster: Weeks 4, 8, 12, and 24
Evaluation of the mean change in disease progression activity using the VIDA score ranking scale.
Weeks 4, 8, 12, and 24
Change From Baseline in Facial Body Surface Area (F-BSA) and Total Body Surface Area (T-BSA)
Zeitfenster: Weeks 4, 8, 12, and 24
Evaluation of the mean changes in percentage values for facial and total body surface area affected by vitiligo.
Weeks 4, 8, 12, and 24
Change From Baseline in F-VASI and T-VASI Scores
Zeitfenster: Weeks 4, 8, 12, and 24
Continuous absolute scoring changes from baseline evaluation across both indices.
Weeks 4, 8, 12, and 24
Proportion of Participants Achieving a Vitiligo Noticeability Scale (VNS) Score of 4 or 5
Zeitfenster: Weeks 4, 8, 12, and 24
Percentage of participants rating their lesions as 4 ("a lot less noticeable") or 5 ("no longer noticeable") on the patient-reported VNS scale, alongside individual category breakdowns.
Weeks 4, 8, 12, and 24

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)
Zeitfenster: Throughout the study period (Up to Week 24)
Assessment of total safety events, with a specific focus on application-site reactions such as acne and pruritus.
Throughout the study period (Up to Week 24)
Proportion of Participants Discontinuing Treatment or Withdrawing Due to Adverse Events
Zeitfenster: Throughout the study period (Up to Week 24)
Evaluation of tolerability based on safety discontinuation metrics.
Throughout the study period (Up to Week 24)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

ShanShan Li

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

20. Juni 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

23. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Juni 2026

Zuerst gepostet (Tatsächlich)

29. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Opzelura-CHN-IIT-001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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