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The purpose of this study is to determine if topical ruxolitinib 1.5% will provide repigmentation in vitiligo lesions.
The hypothesis is that JAK inhibitors can also successfully treat vitiligo. Lesional skin of both alopecia areata and vitiligo primarily contain T cells in a TH1 response as opposed to a mixed cell infiltrate such as in psoriasis or lichen planus. Both alopecia areata and vitiligo are TH1 mediated diseases dependent on the production of IFN-gamma to drive the response. CD8+ T cells are both necessary and sufficient for melanocyte destruction in vitiligo (van den Boorn JG et al 2009) and CD8+NKG2D+ T cells are also necessary and sufficient for hair loss in alopecia areata (Gilhar A et al 2013).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib 1.5% phosphate cream | Experimental | Ruxolitinib 1.5% phosphate cream twice daily to vitiligo patches. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib 1.5% Phosphate Cream | Drug | twice daily topical application of Ruxolitinib 1.5% Phosphate Cream beginning at baseline and ending at week 20 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Vitiligo Area Severity Index (VASI) Score From Baseline to Week 20 | The VASI for each body region (hands, upper extremities, trunk, lower extremities, feet) is determined by the product of the area involved in hand prints and the extent of depigmentation within each hand print unit measured patch (0-100). Area involved is measured by hand prints (1 hand print = 1%) with a possible range of 0-100. Degree of depigmentation is measured as: 1.00 (100%) = complete depigmentation, no pigment present, 0.90(90%)=specks of pigment present, 0.75(75%)=depigmented area exceeds the pigmented area, 0.50(50%)=pigmented and depigmented areas are equal, 0.25(25%)=pigmented area exceeds depigmented area, 0.10(10%)=only specks of depigmentation present, and 0.0(0%)=no depigmentation present. | Baseline to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Surface Area (BSA) of Repigmentation | Area involved is measured by hand prints (1 hand print = 1%) with a possible range of 0-100. | Baseline and Week 20 |
| Number of Subjects Who Achieve a Physician Global Vitiligo Assessment (PGVA) of Clear or Almost Clear |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Rosmarin, MD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ruxolitinib 1.5% Phosphate Cream | Ruxolitinib 1.5% phosphate cream twice daily to vitiligo patches. Ruxolitinib 1.5% Phosphate Cream: twice daily topical application of Ruxolitinib 1.5% Phosphate Cream beginning at baseline and ending at week 20 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ruxolitinib 1.5% Phosphate Cream | Ruxolitinib 1.5% phosphate cream twice daily to vitiligo patches. Ruxolitinib 1.5% Phosphate Cream: twice daily topical application of Ruxolitinib 1.5% Phosphate Cream beginning at baseline and ending at week 20 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Vitiligo Area Severity Index (VASI) Score From Baseline to Week 20 | The VASI for each body region (hands, upper extremities, trunk, lower extremities, feet) is determined by the product of the area involved in hand prints and the extent of depigmentation within each hand print unit measured patch (0-100). Area involved is measured by hand prints (1 hand print = 1%) with a possible range of 0-100. Degree of depigmentation is measured as: 1.00 (100%) = complete depigmentation, no pigment present, 0.90(90%)=specks of pigment present, 0.75(75%)=depigmented area exceeds the pigmented area, 0.50(50%)=pigmented and depigmented areas are equal, 0.25(25%)=pigmented area exceeds depigmented area, 0.10(10%)=only specks of depigmentation present, and 0.0(0%)=no depigmentation present. | Posted | Mean | 95% Confidence Interval | percentage of change in VASI | Baseline to Week 20 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ruxolitinib 1.5% Phosphate Cream | Ruxolitinib 1.5% phosphate cream twice daily to vitiligo patches. Ruxolitinib 1.5% Phosphate Cream: twice daily topical application of Ruxolitinib 1.5% Phosphate Cream beginning at baseline and ending at week 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rim of hyperpigmentation surrounding vitiligo lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Romarin, MD Prinicpal Investigator | Tufts Medical Center | 617 636 7462 | drosmarin@tuftsmedicalcenter.org |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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| Baseline and Week 20 |
| Percent Change in Vitiligo European Task Force (VETF) Assessment - Body Surface Area | Vitiligo European Task Force assessment consisted of three components: Extent of disease reflecting the body surface area (0-100%), disease staging (0-20), and disease progression (-5 +5). Staging is based on cutaneous and hair pigmentation assessing the largest patch in each body area (head/neck, trunk, arms, legs, and hands/feet); Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation, Stage 3= partial hair whitening (<30%), Stage 4= complete hair whitening. Disease progression is based on assessing the largest patch in each body area; Score 0= similar limits, Score 1= progressive vitiligo (ongoing subclinical depigmentation), Score -1= regressive vitiligo (ongoing subclinical repigmentation). Where a higher number indicates more severe disease spread and a negative number indicates improving disease. These three subsets are evaluated and reported independently and not mutually related to each other. | Baseline and Week 20 |
| Mean Dermatology Life Quality Index (DLQI) Scores | DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The percent change was calculated from the mean DLQI at baseline and week 20 | Baseline and Week 20 |
| Percent Change in Vitiligo European Task Force (VETF) Assessment - Disease Staging | Vitiligo European Task Force assessment consisted of three components: Extent of disease reflecting the body surface area (0-100%), disease staging (0-20), and disease progression (-5 +5). Staging is based on cutaneous and hair pigmentation assessing the largest patch in each body area (head/neck, trunk, arms, legs, and hands/feet); Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation, Stage 3= partial hair whitening (<30%), Stage 4= complete hair whitening. Disease progression is based on assessing the largest patch in each body area; Score 0= similar limits, Score 1= progressive vitiligo (ongoing subclinical depigmentation), Score -1= regressive vitiligo (ongoing subclinical repigmentation). Where a higher number indicates more severe disease spread and a negative number indicates improving disease. These three subsets are evaluated and reported independently and not mutually related to each other. | Baseline and Week 20 |
| Percent Change in Vitiligo European Task Force (VETF) Assessment - Disease Progression | Vitiligo European Task Force assessment consisted of three components: Extent of disease reflecting the body surface area (0-100%), disease staging (0-20), and disease progression (-5 +5). Staging is based on cutaneous and hair pigmentation assessing the largest patch in each body area (head/neck, trunk, arms, legs, and hands/feet); Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation, Stage 3= partial hair whitening (<30%), Stage 4= complete hair whitening. Disease progression is based on assessing the largest patch in each body area; Score 0= similar limits, Score 1= progressive vitiligo (ongoing subclinical depigmentation), Score -1= regressive vitiligo (ongoing subclinical repigmentation). Where a higher number indicates more severe disease spread and a negative number indicates improving disease. These three subsets are evaluated and reported independently and not mutually related to each other. | Baseline and Week 20 |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Percent Change in Body Surface Area (BSA) of Repigmentation | Area involved is measured by hand prints (1 hand print = 1%) with a possible range of 0-100. | Posted | Mean | Standard Deviation | percentage of change | Baseline and Week 20 |
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| Secondary | Number of Subjects Who Achieve a Physician Global Vitiligo Assessment (PGVA) of Clear or Almost Clear | Posted | Count of Participants | Participants | Baseline and Week 20 |
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| Secondary | Percent Change in Vitiligo European Task Force (VETF) Assessment - Body Surface Area | Vitiligo European Task Force assessment consisted of three components: Extent of disease reflecting the body surface area (0-100%), disease staging (0-20), and disease progression (-5 +5). Staging is based on cutaneous and hair pigmentation assessing the largest patch in each body area (head/neck, trunk, arms, legs, and hands/feet); Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation, Stage 3= partial hair whitening (<30%), Stage 4= complete hair whitening. Disease progression is based on assessing the largest patch in each body area; Score 0= similar limits, Score 1= progressive vitiligo (ongoing subclinical depigmentation), Score -1= regressive vitiligo (ongoing subclinical repigmentation). Where a higher number indicates more severe disease spread and a negative number indicates improving disease. These three subsets are evaluated and reported independently and not mutually related to each other. | Posted | Mean | Standard Deviation | percent change in body surface area | Baseline and Week 20 |
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| Secondary | Mean Dermatology Life Quality Index (DLQI) Scores | DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The percent change was calculated from the mean DLQI at baseline and week 20 | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 20 |
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| Secondary | Percent Change in Vitiligo European Task Force (VETF) Assessment - Disease Staging | Vitiligo European Task Force assessment consisted of three components: Extent of disease reflecting the body surface area (0-100%), disease staging (0-20), and disease progression (-5 +5). Staging is based on cutaneous and hair pigmentation assessing the largest patch in each body area (head/neck, trunk, arms, legs, and hands/feet); Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation, Stage 3= partial hair whitening (<30%), Stage 4= complete hair whitening. Disease progression is based on assessing the largest patch in each body area; Score 0= similar limits, Score 1= progressive vitiligo (ongoing subclinical depigmentation), Score -1= regressive vitiligo (ongoing subclinical repigmentation). Where a higher number indicates more severe disease spread and a negative number indicates improving disease. These three subsets are evaluated and reported independently and not mutually related to each other. | Posted | Mean | Standard Deviation | percent change in disease staging score | Baseline and Week 20 |
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| Secondary | Percent Change in Vitiligo European Task Force (VETF) Assessment - Disease Progression | Vitiligo European Task Force assessment consisted of three components: Extent of disease reflecting the body surface area (0-100%), disease staging (0-20), and disease progression (-5 +5). Staging is based on cutaneous and hair pigmentation assessing the largest patch in each body area (head/neck, trunk, arms, legs, and hands/feet); Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation, Stage 3= partial hair whitening (<30%), Stage 4= complete hair whitening. Disease progression is based on assessing the largest patch in each body area; Score 0= similar limits, Score 1= progressive vitiligo (ongoing subclinical depigmentation), Score -1= regressive vitiligo (ongoing subclinical repigmentation). Where a higher number indicates more severe disease spread and a negative number indicates improving disease. These three subsets are evaluated and reported independently and not mutually related to each other. | Posted | Mean | Standard Deviation | percent of change | Baseline and Week 20 |
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| 0 |
| 11 |
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| 11 |
| 9 |
| 11 |
| Intermittent erythema over affected lesions | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Transient acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| URI symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Muscle aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| hypercholesterolemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Traumatic blister | Social circumstances | Systematic Assessment |
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| Bee sting | Social circumstances | Systematic Assessment |
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| Dental pain | General disorders | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
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