A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area [BSA]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).

The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include < 30% hair whitening); 4=severe disease, complete depigmentation plus > 30% hair whitening.

T-VASI was measured by the percentage of vitiligo involvement from all body regions (percentage of BSA; assessed by the Investigator) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was derived by multiplying the vitiligo involvement values by the percentage of affected skin for each body site and summing all values (possible range: 0-100; lower scores indicate increased improvement).

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated.

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated.

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated.

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated.

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated.

F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = ([post-Baseline value minus Baseline value]/Baseline value) X 100.

F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = ([post-Baseline value minus Baseline value]/Baseline value) X 100.

An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).

F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically and laterally from the corner of the mouth to the tragus. The area "Face" did not include the surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-Baseline value minus Baseline value]/Baseline value) X 100.

F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically and laterally from the corner of the mouth to the tragus. The area "Face" did not include the surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-Baseline value minus Baseline value]/Baseline value) X 100.

T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-Baseline value minus Baseline value]/Baseline value) X 100.

T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = ([post-Baseline value minus Baseline value]/Baseline value) X 100.

T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Change from Baseline (BL) was calculated as the post-BL value minus the BL value.

T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Change from BL was calculated as the post-BL value minus the BL value.

T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).

T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).

The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).

The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).

The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).

The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).

The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).

The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).

The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).

The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).

The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).

The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).

The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include < 30% hair whitening); 4=severe disease, complete depigmentation plus > 30% hair whitening.

The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include < 30% hair whitening); 4=severe disease, complete depigmentation plus > 30% hair whitening.

The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include < 30% hair whitening); 4=severe disease, complete depigmentation plus > 30% hair whitening.

The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include < 30% hair whitening); 4=severe disease, complete depigmentation plus > 30% hair whitening.

The severity of vitiligo was assessed by the participant using the PaGVA, which has a 5-point scale. The participant was asked the following: How severe is your vitiligo on your face (or total body) with respect to the area covered by white skin? Responses: 0=no white patches (no vitiligo); 1=mild; 2=moderate; 3=severe; 4=very severe.

The severity of vitiligo was assessed by the participant using the PaGVA, which has a 5-point scale. The participant was asked the following: How severe is your vitiligo on your face (or total body) with respect to the area covered by white skin? Responses: 0=no white patches (no vitiligo); 1=mild; 2=moderate; 3=severe; 4=very severe.

The severity of vitiligo was assessed by the participant using the PaGVA, which has a 5-point scale. The participant was asked the following: How severe is your vitiligo on your face (or total body) with respect to the area covered by white skin? Responses: 0=no white patches (no vitiligo); 1=mild; 2=moderate; 3=severe; 4=very severe.

The severity of vitiligo was assessed by the participant using the PaGVA, which has a 5-point scale. The participant was asked the following: How severe is your vitiligo on your face (or total body) with respect to the area covered by white skin? Responses: 0=no white patches (no vitiligo); 1=mild; 2=moderate; 3=severe; 4=very severe.

The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: "Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse.

The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: "Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse.

The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: "Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse.

The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: "Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse.

An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).

A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI. T-VASI was measured by the percentage of vitiligo involvement from all body regions (percentage of BSA; assessed by the Investigator) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was derived by multiplying the vitiligo involvement values by the percentage of affected skin for each body site and summing all values (possible range: 0-100; lower scores indicate increased improvement).

The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include < 30% hair whitening); 4=severe disease, complete depigmentation plus > 30% hair whitening. Time to achieve an F-PhGVA response was defined as the number of days from the date of the first application in the Double-Blind Period to the date of the first evaluation at which the participant met the F-PhGVA score.

The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include < 30% hair whitening); 4=severe disease, complete depigmentation plus > 30% hair whitening. Time to achieve a T-PhGVA response was defined as the number of days from the date of the first application in the Double-Blind Period to the date of the first evaluation at which the participant met the T-PhGVA score.

The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: "Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse. Time to achieve a PaGIC-V response was defined as the number of days from the date of the first application in the Double-Blind Period to the date of the first evaluation at which the participant met the PaGIC-V score.