Trial Outcomes & Findings for A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo (NCT NCT03099304)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

157 participants

Primary outcome timeframe

Baseline; Week 24

Results posted on

2022-11-17

Participant Flow

A total of 157 participants with vitiligo were treated at 26 study centers in the United States.

157 participants were randomized to receive 1 of 4 dose strengths of ruxolitinib cream (0.15% once daily \[QD\], 0.5% QD, 1.5% QD, 1.5% twice daily \[BID\]) or vehicle during the 24-week, double-blind (DB), vehicle-controlled treatment period. After the DB period, 11 participants remained on 0.15% QD, and 42 participants who met criteria were re-randomized to 1 of the 3 higher active blinded treatment groups. All other participants remained on the same treatment regimen through Week 52.

Participant milestones

Participant milestones
Measure	Vehicle Twice Daily (BID) Vehicle cream BID for 24 weeks (double-blind, vehicle-controlled treatment period), followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% once daily (QD), or 0.5% QD for Weeks 24 to 52 (continued double-blind treatment period), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 0.15% QD Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 24 or 52 weeks. Those who did not achieve a 25% improvement in F-VASI score were re-randomized to receive ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening), 1.5% QD in the morning (vehicle cream in the evening), or 1.5% BID for Weeks 24 to 52 (continued double-blind treatment period). All participants applied ruxolitinib cream 1.5% BID in the 104-week open-label extension period.	Ruxolitinib Cream 0.5% QD Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% QD Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% BID Ruxolitinib cream 1.5% BID for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Cross-over Participants who were randomized to vehicle cream BID or to ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) on Day 1 of the double-blind, vehicle-controlled treatment period and received ruxolitinib cream 1.5% BID in the 104-week open-label extension period.
DB Period: Day 1 to Week 24 STARTED	32	31	31	30	33	0
DB Period: Day 1 to Week 24 COMPLETED	27	26	30	26	30	0
DB Period: Day 1 to Week 24 NOT COMPLETED	5	5	1	4	3	0
DB Period: Weeks 24 to 52 STARTED	0	11	45	44	47	0
DB Period: Weeks 24 to 52 COMPLETED	0	10	43	37	45	0
DB Period: Weeks 24 to 52 NOT COMPLETED	0	1	2	7	2	0
104-week Open-Label Extension Period STARTED	0	0	28	21	28	46
104-week Open-Label Extension Period COMPLETED	0	0	11	8	12	23
104-week Open-Label Extension Period NOT COMPLETED	0	0	17	13	16	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Vehicle Twice Daily (BID) Vehicle cream BID for 24 weeks (double-blind, vehicle-controlled treatment period), followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% once daily (QD), or 0.5% QD for Weeks 24 to 52 (continued double-blind treatment period), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 0.15% QD Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 24 or 52 weeks. Those who did not achieve a 25% improvement in F-VASI score were re-randomized to receive ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening), 1.5% QD in the morning (vehicle cream in the evening), or 1.5% BID for Weeks 24 to 52 (continued double-blind treatment period). All participants applied ruxolitinib cream 1.5% BID in the 104-week open-label extension period.	Ruxolitinib Cream 0.5% QD Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% QD Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% BID Ruxolitinib cream 1.5% BID for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Cross-over Participants who were randomized to vehicle cream BID or to ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) on Day 1 of the double-blind, vehicle-controlled treatment period and received ruxolitinib cream 1.5% BID in the 104-week open-label extension period.
DB Period: Day 1 to Week 24 Adverse Event	1	1	0	0	1	0
DB Period: Day 1 to Week 24 Lost to Follow-up	1	1	0	0	0	0
DB Period: Day 1 to Week 24 Reason not specified	0	0	0	1	0	0
DB Period: Day 1 to Week 24 Withdrawal by Subject	3	3	0	2	2	0
DB Period: Day 1 to Week 24 Protocol Violation	0	0	1	1	0	0
DB Period: Weeks 24 to 52 Protocol Violation	0	0	1	0	0	0
DB Period: Weeks 24 to 52 Lost to Follow-up	0	1	1	1	0	0
DB Period: Weeks 24 to 52 Adverse Event	0	0	0	1	1	0
DB Period: Weeks 24 to 52 Withdrawal by Subject	0	0	0	4	1	0
DB Period: Weeks 24 to 52 Reason not specified	0	0	0	1	0	0
104-week Open-Label Extension Period Adverse Event	0	0	1	0	0	0
104-week Open-Label Extension Period Lost to Follow-up	0	0	3	2	1	6
104-week Open-Label Extension Period Physician Decision	0	0	0	0	1	0
104-week Open-Label Extension Period Pregnancy	0	0	0	0	0	1
104-week Open-Label Extension Period Protocol Violation	0	0	0	0	0	1
104-week Open-Label Extension Period Withdrawal by Subject	0	0	9	10	13	15
104-week Open-Label Extension Period Other Reason not specified	0	0	4	1	1	0

Baseline Characteristics

A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vehicle Twice Daily (BID) n=32 Participants Vehicle cream BID for 24 weeks (double-blind, vehicle-controlled treatment period), followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% once daily (QD), or 0.5% QD for Weeks 24 to 52 (continued double-blind treatment period), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 0.15% QD n=31 Participants Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 24 or 52 weeks. Those who did not achieve a 25% improvement in F-VASI score were re-randomized to receive ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening), 1.5% QD in the morning (vehicle cream in the evening), or 1.5% BID for Weeks 24 to 52 (continued double-blind treatment period). All participants applied ruxolitinib cream 1.5% BID in the 104-week open-label extension period.	Ruxolitinib Cream 0.5% QD n=31 Participants Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% QD n=30 Participants Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% BID n=33 Participants Ruxolitinib cream 1.5% BID for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Total n=157 Participants Total of all reporting groups
Age, Continuous	46.3 Years STANDARD_DEVIATION 13.11 • n=5 Participants	45.1 Years STANDARD_DEVIATION 11.46 • n=7 Participants	53.8 Years STANDARD_DEVIATION 14.34 • n=5 Participants	46.7 Years STANDARD_DEVIATION 11.73 • n=4 Participants	49.5 Years STANDARD_DEVIATION 12.28 • n=21 Participants	48.3 Years STANDARD_DEVIATION 12.85 • n=10 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	18 Participants n=7 Participants	12 Participants n=5 Participants	19 Participants n=4 Participants	15 Participants n=21 Participants	84 Participants n=10 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants	11 Participants n=4 Participants	18 Participants n=21 Participants	73 Participants n=10 Participants
Race/Ethnicity, Customized Hispanic or Latino	10 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	33 Participants n=10 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	21 Participants n=5 Participants	22 Participants n=7 Participants	23 Participants n=5 Participants	21 Participants n=4 Participants	27 Participants n=21 Participants	114 Participants n=10 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	7 Participants n=10 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized Captured as "Other"	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Race/Ethnicity, Customized White/Caucasian	26 Participants n=5 Participants	29 Participants n=7 Participants	25 Participants n=5 Participants	23 Participants n=4 Participants	29 Participants n=21 Participants	132 Participants n=10 Participants
Race/Ethnicity, Customized Black/African-American	5 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	14 Participants n=10 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants
Race/Ethnicity, Customized Mexican	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized Nigerian/West African	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized Cuban	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized Spanish	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized Caucasian, Black, and Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Facial Body Surface Area (F-BSA) Involvement	1.44 percentage of facial surface area STANDARD_DEVIATION 0.838 • n=5 Participants	1.35 percentage of facial surface area STANDARD_DEVIATION 0.858 • n=7 Participants	1.40 percentage of facial surface area STANDARD_DEVIATION 0.760 • n=5 Participants	1.67 percentage of facial surface area STANDARD_DEVIATION 0.953 • n=4 Participants	1.55 percentage of facial surface area STANDARD_DEVIATION 0.892 • n=21 Participants	1.48 percentage of facial surface area STANDARD_DEVIATION 0.858 • n=10 Participants
Total Body Surface Area (T-BSA) Involvement	23.54 percentage of total body surface area STANDARD_DEVIATION 20.960 • n=5 Participants	17.56 percentage of total body surface area STANDARD_DEVIATION 10.925 • n=7 Participants	22.96 percentage of total body surface area STANDARD_DEVIATION 21.449 • n=5 Participants	24.81 percentage of total body surface area STANDARD_DEVIATION 20.056 • n=4 Participants	21.46 percentage of total body surface area STANDARD_DEVIATION 16.820 • n=21 Participants	22.05 percentage of total body surface area STANDARD_DEVIATION 18.377 • n=10 Participants
Face Vitiligo Area Scoring Index (F-VASI)	1.21 scores on a scale STANDARD_DEVIATION 0.845 • n=5 Participants	1.19 scores on a scale STANDARD_DEVIATION 0.754 • n=7 Participants	1.22 scores on a scale STANDARD_DEVIATION 0.705 • n=5 Participants	1.45 scores on a scale STANDARD_DEVIATION 0.980 • n=4 Participants	1.26 scores on a scale STANDARD_DEVIATION 0.807 • n=21 Participants	1.26 scores on a scale STANDARD_DEVIATION 0.817 • n=10 Participants
Total Body Vitiligo Area Scoring Index (T-VASI)	19.40 scores on a scale STANDARD_DEVIATION 18.512 • n=5 Participants	14.57 scores on a scale STANDARD_DEVIATION 9.049 • n=7 Participants	18.43 scores on a scale STANDARD_DEVIATION 15.363 • n=5 Participants	20.55 scores on a scale STANDARD_DEVIATION 18.488 • n=4 Participants	16.94 scores on a scale STANDARD_DEVIATION 14.256 • n=21 Participants	17.96 scores on a scale STANDARD_DEVIATION 15.451 • n=10 Participants

PRIMARY outcome

Timeframe: Baseline; Week 24

Population: Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were to be defined according to the treatment assignment at the time of randomization regardless of the actual ruxolitinib cream or vehicle cream participants might have applied during their participation in the study. Missing post-Baseline values were considered as not having achieved responses for visits up to Week 52.

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).

Outcome measures

Outcome measures
Measure	Vehicle Twice Daily (BID) n=32 Participants Vehicle cream BID for 24 weeks (double-blind, vehicle-controlled treatment period), followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% once daily (QD), or 0.5% QD for Weeks 24 to 52 (continued double-blind treatment period), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 0.15% QD n=31 Participants Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 24 or 52 weeks. Those who did not achieve a 25% improvement in F-VASI score were re-randomized to receive ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening), 1.5% QD in the morning (vehicle cream in the evening), or 1.5% BID for Weeks 24 to 52 (continued double-blind treatment period). All participants applied ruxolitinib cream 1.5% BID in the 104-week open-label extension period.	Ruxolitinib Cream 0.5% QD n=31 Participants Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% QD n=30 Participants Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% BID n=33 Participants Ruxolitinib cream 1.5% BID for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% QD: 1.5 % BID Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% BID: 1.5% BID Ruxolitinib cream 1.5% BID for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.
Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24	3.1 percentage of participants	32.3 percentage of participants	25.8 percentage of participants	50.0 percentage of participants	45.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 24

Population: ITT Population. Missing post-Baseline values were considered as not having achieved F-PhGVA response for visits up to Week 24.

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.

Outcome measures

Outcome measures
Measure	Vehicle Twice Daily (BID) n=32 Participants Vehicle cream BID for 24 weeks (double-blind, vehicle-controlled treatment period), followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% once daily (QD), or 0.5% QD for Weeks 24 to 52 (continued double-blind treatment period), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 0.15% QD n=31 Participants Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 24 or 52 weeks. Those who did not achieve a 25% improvement in F-VASI score were re-randomized to receive ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening), 1.5% QD in the morning (vehicle cream in the evening), or 1.5% BID for Weeks 24 to 52 (continued double-blind treatment period). All participants applied ruxolitinib cream 1.5% BID in the 104-week open-label extension period.	Ruxolitinib Cream 0.5% QD n=31 Participants Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% QD n=30 Participants Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% BID n=33 Participants Ruxolitinib cream 1.5% BID for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% QD: 1.5 % BID Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% BID: 1.5% BID Ruxolitinib cream 1.5% BID for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.
Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear	0 percentage of participants	3.2 percentage of participants	9.7 percentage of participants	13.3 percentage of participants	9.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: ITT Population. Missing post-Baseline values were considered as not having achieved responses for visits up to Week 52. Only participants with available data were analyzed.

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).

Outcome measures

Outcome measures
Measure	Vehicle Twice Daily (BID) n=10 Participants Vehicle cream BID for 24 weeks (double-blind, vehicle-controlled treatment period), followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% once daily (QD), or 0.5% QD for Weeks 24 to 52 (continued double-blind treatment period), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 0.15% QD n=14 Participants Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 24 or 52 weeks. Those who did not achieve a 25% improvement in F-VASI score were re-randomized to receive ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening), 1.5% QD in the morning (vehicle cream in the evening), or 1.5% BID for Weeks 24 to 52 (continued double-blind treatment period). All participants applied ruxolitinib cream 1.5% BID in the 104-week open-label extension period.	Ruxolitinib Cream 0.5% QD n=12 Participants Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% QD n=13 Participants Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% BID n=31 Participants Ruxolitinib cream 1.5% BID for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% QD: 1.5 % BID n=30 Participants Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% BID: 1.5% BID n=33 Participants Ruxolitinib cream 1.5% BID for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.
Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52	50 percentage of participants	21.4 percentage of participants	16.7 percentage of participants	15.4 percentage of participants	25.8 percentage of participants	30.0 percentage of participants	36.4 percentage of participants

SECONDARY outcome

Population: ITT Population

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.

Outcome measures

Outcome measures
Measure	Vehicle Twice Daily (BID) n=32 Participants Vehicle cream BID for 24 weeks (double-blind, vehicle-controlled treatment period), followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% once daily (QD), or 0.5% QD for Weeks 24 to 52 (continued double-blind treatment period), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 0.15% QD n=31 Participants Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 24 or 52 weeks. Those who did not achieve a 25% improvement in F-VASI score were re-randomized to receive ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening), 1.5% QD in the morning (vehicle cream in the evening), or 1.5% BID for Weeks 24 to 52 (continued double-blind treatment period). All participants applied ruxolitinib cream 1.5% BID in the 104-week open-label extension period.	Ruxolitinib Cream 0.5% QD n=31 Participants Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% QD n=30 Participants Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% BID n=33 Participants Ruxolitinib cream 1.5% BID for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% QD: 1.5 % BID Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 1.5% BID: 1.5% BID Ruxolitinib cream 1.5% BID for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.
Time to Achieve a PaGIC-V of Very Much Improved or Much Improved	NA days The median and the upper and lower limits of the confidence interval were not estimable because too few participants achieved a PaGIC-V of very much improved or much improved.	NA days Interval 274.0 to The median and the upper limit of the confidence interval were not estimable because too few participants achieved a PaGIC-V of very much improved or much improved.	NA days Interval 290.0 to The median and the upper limit of the confidence interval were not estimable because too few participants achieved a PaGIC-V of very much improved or much improved.	282.0 days Interval 169.0 to The upper limit of the confidence interval was not estimable because too few participants achieved a PaGIC-V of very much improved or much improved.	281.0 days Interval 178.0 to The upper limit of the confidence interval was not estimable because too few participants achieved a PaGIC-V of very much improved or much improved.	—	—

Adverse Events

Vehicle Twice Daily (BID)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Ruxolitinib Cream 0.15% Once Daily (QD)

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Ruxolitinib Cream 0.5% QD

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

Ruxolitinib Cream 1.5% QD

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Ruxolitinib Cream 1.5% BID

Serious events: 4 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vehicle Twice Daily (BID) n=32 participants at risk Vehicle cream BID for 24 weeks (double-blind, vehicle-controlled treatment period), followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% once daily (QD), or 0.5% QD for Weeks 24 to 52 (continued double-blind treatment period), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 0.15% Once Daily (QD) n=31 participants at risk All participants who received at least one dose of ruxolitinib cream 0.15% QD (in the 52-week combined vehicle-controlled and continued double-blind periods).	Ruxolitinib Cream 0.5% QD n=45 participants at risk All participants who received at least one dose of ruxolitinib cream 0.5% QD. Treatment was received by participants for 52 weeks in the combined vehicle-controlled and continued double-blind periods, and by those participants who were randomized to the vehicle group or were randomized to ruxolitinib cream 0.15% QD and did not achieve 25% improvement in F-VASI score at Week 24 and crossed over to 0.5% QD for 28 weeks (Week 24 to Week 52 \[continued double-blind treatment period\]).	Ruxolitinib Cream 1.5% QD n=44 participants at risk All participants who received at least one dose of ruxolitinib cream 1.5% QD. Treatment was received by participants for 52 weeks in the combined vehicle-controlled and continued double-blind periods, and by those participants who were randomized to the vehicle group or were randomized to ruxolitinib cream 0.15% QD and did not achieve 25% improvement in F-VASI score at Week 24 and crossed over to 1.5% QD for 28 weeks (Week 24 to Week 52 \[continued double-blind treatment period\]).	Ruxolitinib Cream 1.5% BID n=130 participants at risk All participants who received at least one dose of ruxolitinib cream 1.5% BID. Treatment was received by (1) participants randomized to ruxolitinib cream 1.5% BID through Week 156, (2) participants who were randomized to the vehicle group or were randomized to ruxolitinib cream 0.15% QD and did not achieve 25% improvement in F-VASI score at Week 24 and crossed over to 1.5% BID for 28 weeks (Week 24 to Week 52 \[continued double-blind treatment period\]), and (3) participants who were (a) randomized to the vehicle group, (b) to ruxolitinib cream 0.15% QD and achieved 25% improvement in F-VASI score at Week 24, (c) to ruxolitinib cream 0.5% QD, and (d) to ruxolitinib cream 1.5% QD who crossed over to 1.5% BID during the open-label extension period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/32 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/31 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/45 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/44 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.77% 1/130 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/32 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/31 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/45 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/44 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.77% 1/130 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Cardiac disorders Coronary artery occlusion	0.00% 0/32 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/31 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.2% 1/45 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/44 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/130 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Gastrointestinal disorders Oesophageal achalasia	0.00% 0/32 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/31 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.2% 1/45 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/44 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/130 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/32 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/31 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/45 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/44 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.77% 1/130 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Nervous system disorders Seizure	0.00% 0/32 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/31 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/45 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.3% 1/44 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/130 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/32 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/31 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/45 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/44 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.77% 1/130 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.

Other adverse events

Other adverse events
Measure	Vehicle Twice Daily (BID) n=32 participants at risk Vehicle cream BID for 24 weeks (double-blind, vehicle-controlled treatment period), followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% once daily (QD), or 0.5% QD for Weeks 24 to 52 (continued double-blind treatment period), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period.	Ruxolitinib Cream 0.15% Once Daily (QD) n=31 participants at risk All participants who received at least one dose of ruxolitinib cream 0.15% QD (in the 52-week combined vehicle-controlled and continued double-blind periods).	Ruxolitinib Cream 0.5% QD n=45 participants at risk All participants who received at least one dose of ruxolitinib cream 0.5% QD. Treatment was received by participants for 52 weeks in the combined vehicle-controlled and continued double-blind periods, and by those participants who were randomized to the vehicle group or were randomized to ruxolitinib cream 0.15% QD and did not achieve 25% improvement in F-VASI score at Week 24 and crossed over to 0.5% QD for 28 weeks (Week 24 to Week 52 \[continued double-blind treatment period\]).	Ruxolitinib Cream 1.5% QD n=44 participants at risk All participants who received at least one dose of ruxolitinib cream 1.5% QD. Treatment was received by participants for 52 weeks in the combined vehicle-controlled and continued double-blind periods, and by those participants who were randomized to the vehicle group or were randomized to ruxolitinib cream 0.15% QD and did not achieve 25% improvement in F-VASI score at Week 24 and crossed over to 1.5% QD for 28 weeks (Week 24 to Week 52 \[continued double-blind treatment period\]).	Ruxolitinib Cream 1.5% BID n=130 participants at risk All participants who received at least one dose of ruxolitinib cream 1.5% BID. Treatment was received by (1) participants randomized to ruxolitinib cream 1.5% BID through Week 156, (2) participants who were randomized to the vehicle group or were randomized to ruxolitinib cream 0.15% QD and did not achieve 25% improvement in F-VASI score at Week 24 and crossed over to 1.5% BID for 28 weeks (Week 24 to Week 52 \[continued double-blind treatment period\]), and (3) participants who were (a) randomized to the vehicle group, (b) to ruxolitinib cream 0.15% QD and achieved 25% improvement in F-VASI score at Week 24, (c) to ruxolitinib cream 0.5% QD, and (d) to ruxolitinib cream 1.5% QD who crossed over to 1.5% BID during the open-label extension period.
Gastrointestinal disorders Abdominal pain	6.2% 2/32 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/31 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.2% 1/45 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/44 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	1.5% 2/130 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Skin and subcutaneous tissue disorders Acne	3.1% 1/32 • Number of events 7 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	12.9% 4/31 • Number of events 4 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	11.1% 5/45 • Number of events 12 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	9.1% 4/44 • Number of events 5 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	9.2% 12/130 • Number of events 14 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
General disorders Application site erythema	3.1% 1/32 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	6.5% 2/31 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/45 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	6.8% 3/44 • Number of events 3 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.77% 1/130 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
General disorders Application site exfoliation	0.00% 0/32 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	6.5% 2/31 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/45 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.3% 1/44 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	1.5% 2/130 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
General disorders Application site pruritus	9.4% 3/32 • Number of events 3 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	19.4% 6/31 • Number of events 8 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	6.7% 3/45 • Number of events 3 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	6.8% 3/44 • Number of events 4 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	1.5% 2/130 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Infections and infestations Bronchitis	0.00% 0/32 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	16.1% 5/31 • Number of events 5 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/45 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.3% 1/44 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	4.6% 6/130 • Number of events 6 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Skin and subcutaneous tissue disorders Dermatitis contact	9.4% 3/32 • Number of events 3 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/31 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.2% 1/45 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	4.5% 2/44 • Number of events 3 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.77% 1/130 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Skin and subcutaneous tissue disorders Erythema	6.2% 2/32 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/31 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	4.4% 2/45 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/44 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.3% 3/130 • Number of events 3 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Nervous system disorders Headache	9.4% 3/32 • Number of events 4 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	3.2% 1/31 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/45 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	6.8% 3/44 • Number of events 3 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	1.5% 2/130 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Infections and infestations Nasopharyngitis	12.5% 4/32 • Number of events 4 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	12.9% 4/31 • Number of events 5 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	11.1% 5/45 • Number of events 6 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	11.4% 5/44 • Number of events 6 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	4.6% 6/130 • Number of events 6 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Gastrointestinal disorders Nausea	0.00% 0/32 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	6.5% 2/31 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	4.4% 2/45 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.3% 1/44 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/130 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Infections and infestations Oral herpes	0.00% 0/32 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	6.5% 2/31 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.2% 1/45 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.3% 1/44 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	3.1% 4/130 • Number of events 5 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
General disorders Pain	6.2% 2/32 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/31 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.2% 1/45 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	4.5% 2/44 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.77% 1/130 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Skin and subcutaneous tissue disorders Pruritus	9.4% 3/32 • Number of events 5 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	3.2% 1/31 • Number of events 3 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	11.1% 5/45 • Number of events 5 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	11.4% 5/44 • Number of events 8 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	4.6% 6/130 • Number of events 6 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Skin and subcutaneous tissue disorders Rash	6.2% 2/32 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/31 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.2% 1/45 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	4.5% 2/44 • Number of events 3 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.77% 1/130 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Infections and infestations Sinusitis	3.1% 1/32 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	6.5% 2/31 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.2% 1/45 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	4.5% 2/44 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	6.9% 9/130 • Number of events 11 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Skin and subcutaneous tissue disorders Skin exfoliation	3.1% 1/32 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	9.7% 3/31 • Number of events 3 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.2% 1/45 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.3% 1/44 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.77% 1/130 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/32 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	6.5% 2/31 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/45 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/44 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	1.5% 2/130 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Infections and infestations Upper respiratory tract infection	0.00% 0/32 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	3.2% 1/31 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	11.1% 5/45 • Number of events 5 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	2.3% 1/44 • Number of events 3 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	6.2% 8/130 • Number of events 12 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Infections and infestations Urinary tract infection	0.00% 0/32 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	3.2% 1/31 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/45 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	6.8% 3/44 • Number of events 3 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.77% 1/130 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.
Skin and subcutaneous tissue disorders Urticaria	3.1% 1/32 • Number of events 1 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/31 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	4.4% 2/45 • Number of events 2 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	6.8% 3/44 • Number of events 3 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.	0.00% 0/130 • Up to 180 weeks (156-week treatment period plus 6-month follow-up period) 157 participants received 1 of 4 doses of ruxolitinib cream or vehicle during the 24-week, DB period. After the DB period, 11 stayed on 0.15% QD and 42 were re-randomized to 1 of 3 higher groups. All others remained on the same treatment regimen through Week 52. 47 randomized to the 1.5% BID arm during Week 52 stayed during the OL period and 83 from the 3 lower dose arms (0.15% QD, 0.5% QD, and 1.5% QD) crossed over to the 1.5% BID arm during the OL period, totaling 130 at risk at data cut-off.

Additional Information

Incyte Corporation Call Center (US)

Incyte

Phone: 1.855.463.3463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Clinical Study Agreement
Publication restrictions are in place

Restriction type: OTHER