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 |
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.
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
8103 Clearvista Parkway
Indianapolis, Indiana 46256
Indianapolis, Indiana 46256
Phone: 317-621-7731
Click here to add this to my saved trials
711 East Lamar Boulevard
Arlington, Texas 76011
Arlington, Texas 76011
Phone: 817-795-7546
Click here to add this to my saved trials
Click here to add this to my saved trials
1802 6th Avenue South
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Phone: 205-502-9967
Click here to add this to my saved trials
260 Tremont Street
Boston, Massachusetts 02111
Boston, Massachusetts 02111
Phone: 617-636-7462
Click here to add this to my saved trials
676 North Saint Clair Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Phone: 312-503-5902
Click here to add this to my saved trials
3900 Junius Street
Dallas, Texas 75246
Dallas, Texas 75246
Phone: 972-354-7993
Click here to add this to my saved trials
5323 Harry Hines Boulevard
Dallas, Texas 75390
Dallas, Texas 75390
Phone: 214-645-2400
Click here to add this to my saved trials
27 Hospital Avenue
Danbury, Connecticut 06810
Danbury, Connecticut 06810
Phone: 203-616-2710
Click here to add this to my saved trials
3031 West Grand Boulevard
Detroit, Michigan 48059
Detroit, Michigan 48059
Phone: 313-916-6964
Click here to add this to my saved trials
3633 Central Avenue
Hot Springs, Arkansas 71913
Hot Springs, Arkansas 71913
Phone: 501-620-4449
Click here to add this to my saved trials
Los Angeles, California 90036
Phone: 323-467-4389
Click here to add this to my saved trials
8930 South Sepulveda Boulevard
Los Angeles, California 90045
Los Angeles, California 90045
Phone: 310-337-7171
Click here to add this to my saved trials
3810 Springhurst Boulevard
New Albany, Indiana 47150
New Albany, Indiana 47150
Phone: 502-373-2849
Click here to add this to my saved trials
1415 Tulane Avenue
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Phone: 504-988-5135
Click here to add this to my saved trials
5 East 98th Street
New York, New York 11209
New York, New York 11209
Phone: 212-241-3288
Click here to add this to my saved trials
900 North Porter Avenue
Norman, Oklahoma 73071
Norman, Oklahoma 73071
Phone: 405-329-0474
Click here to add this to my saved trials
3629 Vista Way
Oceanside, California 92056
Oceanside, California 92056
Phone: 760-757-7546
Click here to add this to my saved trials
1400 Hand Avenue
Ormond Beach, Florida 32174
Ormond Beach, Florida 32174
Phone: 386-523-0768
Click here to add this to my saved trials
110 Corporate Drive
Portsmouth, New Hampshire 03801
Portsmouth, New Hampshire 03801
Phone: 603-319-8863
Click here to add this to my saved trials
593 Eddy Street
Providence, Rhode Island 02903
Providence, Rhode Island 02903
Phone: 401-444-7853
Click here to add this to my saved trials
Rogers, Arkansas 72758
Phone: 479-876-8205
Click here to add this to my saved trials
969 North Mason Road
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Phone: 314-362-8171
Click here to add this to my saved trials
7810 Louis Pasteur Drive
San Antonio, Texas 78229
San Antonio, Texas 78229
Phone: 210-692-1382
Click here to add this to my saved trials
1 Medical Center Boulevard
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Phone: 336-716-8991
Click here to add this to my saved trials
55 North Lake Avenue
Worcester, Massachusetts 01605
Worcester, Massachusetts 01605
Phone: 508-334-5979
Click here to add this to my saved trials