A Study of Ruxolitinib Phosphate Cream in Subjects With Vitiligo



Status:Active, not recruiting
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:3/29/2019
Start Date:April 19, 2017
End Date:July 2020

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A Randomized, Double-Blind, Dose-Ranging Study of Ruxolitinib Phosphate Cream in Subjects With Vitiligo

The purpose of this study is to examine the efficacy, safety, and tolerability of ruxolitinib
cream in subjects with vitiligo.


Inclusion Criteria:

- Clinical diagnosis of vitiligo.

- Vitiligo with depigmented areas including:

- at least 0.5% of the total body surface area (BSA) on the face (0.5% BSA is
approximately equal to the area of the participant's palm [without digits]) AND

- at least 3% of the total BSA on nonfacial areas (3% BSA is approximately equal to
the area of 3 of the participant's handprints [palm plus 5 digits]).

- Participants who agree to discontinue all agents used to treat vitiligo from screening
through the final follow-up visit. Over-the-counter preparations deemed acceptable by
the investigator and camouflage makeups are permitted.

Exclusion Criteria:

- Conditions at baseline that would interfere with evaluation of vitiligo.

- Participants who are receiving any kind of phototherapy, including tanning beds.

- Participants with other dermatologic disease besides vitiligo whose presence or
treatments could complicate the assessment of repigmentation.

- Participants who have used skin bleaching treatments for past treatment of vitiligo or
other pigmented areas.

- Participants who have received any of the following treatments within the minimum
specified timeframes.

- Use of any biologic, investigational, or experimental therapy or procedure for
vitiligo within 12 weeks or 5 half-lives (whichever is longer) of screening.

- Use of laser or light-based vitiligo treatments, including tanning beds, within 8
weeks of screening.

- Use of immunomodulating oral or systemic medications (eg, corticosteroids,
methotrexate, cyclosporine) or topical treatments that may affect vitiligo (eg,
corticosteroids, tacrolimus/pimecrolimus, retinoids) within 4 weeks of screening.

- Use of any prior and concomitant therapy not listed above that may interfere with the
objective of the study as per discretion of the investigator, including drugs that
cause photosensitivity or skin pigmentation (eg, antibiotics such as tetracyclines,
antifungals) within 8 weeks of screening.

- Participants with a clinically significant abnormal thyroid-stimulating hormone or
free T4 at screening.

- Participants with protocol-defined cytopenias at screening

- Participants with severely impaired liver function.

- Participants with impaired renal function.

- Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole
within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit.

- Participants who have previously received JAK inhibitor therapy, systemic or topical.
We found this trial at
26
sites
55 North Lake Avenue
Worcester, Massachusetts 01605
Phone: 508-334-5979
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711 East Lamar Boulevard
Arlington, Texas 76011
Phone: 817-795-7546
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1364 Clifton Road
Atlanta, Georgia 30322
Phone: 404-778-3084
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1802 6th Avenue South
Birmingham, Alabama 35233
Phone: 205-502-9967
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260 Tremont Street
Boston, Massachusetts 02111
Phone: 617-636-7462
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676 North Saint Clair Street
Chicago, Illinois 60611
Phone: 312-503-5902
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3900 Junius Street
Dallas, Texas 75246
Phone: 972-354-7993
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5323 Harry Hines Boulevard
Dallas, Texas 75390
Phone: 214-645-2400
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27 Hospital Avenue
Danbury, Connecticut 06810
Phone: 203-616-2710
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3031 West Grand Boulevard
Detroit, Michigan 48059
Phone: 313-916-6964
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3633 Central Avenue
Hot Springs, Arkansas 71913
Phone: 501-620-4449
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8103 Clearvista Parkway
Indianapolis, Indiana 46256
Phone: 317-621-7731
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8930 South Sepulveda Boulevard
Los Angeles, California 90045
Phone: 310-337-7171
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3810 Springhurst Boulevard
New Albany, Indiana 47150
Phone: 502-373-2849
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1415 Tulane Avenue
New Orleans, Louisiana 70112
Phone: 504-988-5135
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5 East 98th Street
New York, New York 11209
Phone: 212-241-3288
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900 North Porter Avenue
Norman, Oklahoma 73071
Phone: 405-329-0474
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3629 Vista Way
Oceanside, California 92056
Phone: 760-757-7546
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1400 Hand Avenue
Ormond Beach, Florida 32174
Phone: 386-523-0768
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110 Corporate Drive
Portsmouth, New Hampshire 03801
Phone: 603-319-8863
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593 Eddy Street
Providence, Rhode Island 02903
Phone: 401-444-7853
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Rogers, AR
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969 North Mason Road
Saint Louis, Missouri 63141
Phone: 314-362-8171
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7810 Louis Pasteur Drive
San Antonio, Texas 78229
Phone: 210-692-1382
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1 Medical Center Boulevard
Winston-Salem, North Carolina 27157
Phone: 336-716-8991
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