A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)

  • End date
    Jun 22, 2023
  • participants needed
  • sponsor
    Incyte Corporation
Updated on 11 April 2022
skin biopsy


The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.

Condition Vitiligo
Treatment Vehicle cream, Ruxolitinib cream
Clinical Study IdentifierNCT04896385
SponsorIncyte Corporation
Last Modified on11 April 2022


Yes No Not Sure

Inclusion Criteria

A clinical diagnosis of nonsegmental vitiligo with depigmented areas including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, and ≥ 3 T-VASI; total body vitiligo area (facial and nonfacial) should not exceed 50% BSA
At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy
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 (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor)
Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas except hydroquinone
Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments
Conditions at baseline that would interfere with evaluation of vitiligo
Use of any protocol-defined treatments within the indicated washout period before baseline
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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