Vitiligo
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Vitiligo
INCB 18424-217 Enrolling

Research Trial for Participants with Vitiligo (14 Months)


Treatment: Topical Age: 12 Years

Individuals aged 12 or older with a clinical diagnosis of nonsegmental vitiligo with depigmented areas, may qualify to participate. Qualified participants must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Participants must not have other forms of vitiligo (e.g. segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders.

Participants will receive investigational topical cream (active Study Drug) either alone or in combination with home-based phototherapy. Study medication, phototherapy device, and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.

Study participation will last about 14 months and involve about 10 visits to the study centre, plus a safety follow-up visit.


The following information is from ClinicalTrials.gov

Last Update Posted: November 27, 2022

Official Title

A Safety and Efficacy Study of Ruxolitinib Cream Combined With Narrow-Band Ultraviolet B Phototherapy in Participants With Vitiligo

ClinicalTrials.gov ID

NCT05247489

Sponsor

Incyte Corporation

Study Description

  • Brief Summary:

    The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream with or without phototherapy in adolescent and adult participants with non-segmental vitiligo for whom vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

  • Condition or Disease:

    Vitiligo

  • Intervention/Treatment:

    Drug: Ruxolitinib 1.5% cream
    Drug: Ruxolitinib 1.5% cream
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    12 Years and 99 Years (Child)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

A clinical diagnosis of nonsegmental vitiligo with depigmented area including all of the following:

≥ 0.5 F-VASI on the face
≥ 3.0 T-VASI (body areas not including the face)
Total body vitiligo area (facial and nonfacial) not exceeding 10% BSA.
Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.

Exclusion Criteria:

No pigmented hair within any of the vitiligo areas on the face.
Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders.
Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
Previous adverse reaction to NB-UVB phototherapy that caused discontinuation of therapy.
Lack of response (little or no repigmentation) to prior NB-UVB phototherapy.
History of thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke, myocardial infarction).
Any other skin disease that, in the opinion of the investigator, would interfere with the study cream application or study assessments.
Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox) within 1 week before baseline.
Any serious illness or medical, physical, or psychiatric condition(s) that pose a significant risk to the participant; or interfere with interpretation of study data.
Recent use of topical or systemic medications (including biologics or JAK inhibitors), or laser or phototherapy to treat vitiligo. Note: Recent may be defined differently for different treatments.
Specific protocol-defined chemistry, hematology, and serological lab values.
Those who are pregnant, lactating or considering pregnancy during the period of study participation.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations


Participating Experts

Dr. Charles Lynde

Dermatologist

Dr. Maryam Shayesteh Alam

Dermatologist

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