Trial Outcomes & Findings for A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis (NCT NCT00778700)
NCT ID: NCT00778700
Last Updated: 2022-02-09
Results Overview
Total Lesion Score is calculated as the sum of component scores for erythema (E), scaling (S), and thickness (T) of the study-treated lesions taken together. Each component consists of ratings of 0=none, 1=mild, 2=moderate, 3=marked, and 4=severe such that total lesion score can vary in value from 0 to 12. A negative change from Baseline indicates improvement.
COMPLETED
PHASE2
199 participants
From Baseline (Day 1) to Day 84
2022-02-09
Participant Flow
A total of 199 participants were enrolled at 27 sites in the United States from 28 October 2008 to 26 June 2009.
220 participants with stable plaque psoriasis were enrolled in the study, 199 of whom received randomized study drug and were analyzed in this study. 21 subjects did not receive study drug and were therefore excluded from the ITT and Safety analysis sets. The participants were randomized in 1:1:1:1 ratio to receive vehicle cream or Ruxolitinib phosphate 0.5% cream or Ruxolitinib phosphate 1.0% cream or Ruxolitinib phosphate 1.5% cream.
Participant milestones
| Measure |
Vehicle Cream
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
49
|
49
|
|
Overall Study
COMPLETED
|
32
|
44
|
43
|
36
|
|
Overall Study
NOT COMPLETED
|
18
|
7
|
6
|
13
|
Reasons for withdrawal
| Measure |
Vehicle Cream
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
1
|
3
|
5
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
0
|
|
Overall Study
Subject Withdrew Consent
|
6
|
4
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
0
|
1
|
|
Overall Study
Reason not Specified
|
2
|
0
|
1
|
3
|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Vehicle
n=50 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=51 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=49 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=49 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 10.94 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 10.91 • n=7 Participants
|
44.9 years
STANDARD_DEVIATION 13.03 • n=5 Participants
|
43.6 years
STANDARD_DEVIATION 12.80 • n=4 Participants
|
44.0 years
STANDARD_DEVIATION 11.92 • n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
173 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian Native
|
45 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
185 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Total Lesion Score
|
7.2 score on a scale
n=5 Participants
|
7.1 score on a scale
n=7 Participants
|
6.7 score on a scale
n=5 Participants
|
7.1 score on a scale
n=4 Participants
|
7.0 score on a scale
n=21 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) to Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
Total Lesion Score is calculated as the sum of component scores for erythema (E), scaling (S), and thickness (T) of the study-treated lesions taken together. Each component consists of ratings of 0=none, 1=mild, 2=moderate, 3=marked, and 4=severe such that total lesion score can vary in value from 0 to 12. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vehicle Cream
n=47 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=49 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=49 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=48 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84
|
-1.07 score on a scale
Standard Error 0.290
|
-2.25 score on a scale
Standard Error 0.284
|
-2.47 score on a scale
Standard Error 0.285
|
-2.27 score on a scale
Standard Error 0.287
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vehicle Cream
n=47 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=49 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=48 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=48 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness
|
-0.45 score on a scale
Standard Deviation 0.775
|
-0.71 score on a scale
Standard Deviation 0.677
|
0.84 score on a scale
Standard Deviation 0.898
|
-0.90 score on a scale
Standard Deviation 0.778
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vehicle Cream
n=33 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=44 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=45 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=39 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema
|
-0.45 score on a scale
Standard Deviation 0.711
|
-0.59 score on a scale
Standard Deviation 0.757
|
-0.72 score on a scale
Standard Deviation 0.889
|
-0.64 score on a scale
Standard Deviation 0.872
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vehicle Cream
n=33 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=44 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=45 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=39 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling
|
-0.46 score on a scale
Standard Deviation 0.972
|
-0.91 score on a scale
Standard Deviation 0.741
|
-0.87 score on a scale
Standard Deviation 0.991
|
-0.85 score on a scale
Standard Deviation 0.961
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.
Outcome measures
| Measure |
Vehicle Cream
n=47 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=49 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=49 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=48 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness
|
-17.37 percent change
Standard Deviation 31.075
|
-30.95 percent change
Standard Deviation 27.851
|
-36.56 percent change
Standard Deviation 38.447
|
-36.80 percent change
Standard Deviation 33.016
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.
Outcome measures
| Measure |
Vehicle Cream
n=33 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=44 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=45 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=39 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema
|
-15.40 percent change
Standard Deviation 22.146
|
-22.53 percent change
Standard Deviation 27.702
|
-30.74 percent change
Standard Deviation 39.404
|
-23.93 percent change
Standard Deviation 35.828
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.
Outcome measures
| Measure |
Vehicle Cream
n=33 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=44 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=45 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=39 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling
|
-17.68 percent change
Standard Deviation 38.175
|
-37.13 percent change
Standard Deviation 28.050
|
-35.38 percent change
Standard Deviation 44.140
|
-36.11 percent change
Standard Deviation 41.286
|
SECONDARY outcome
Timeframe: Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population.
Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure.
Outcome measures
| Measure |
Vehicle Cream
n=50 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=51 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=49 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=49 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84
|
25.5 percentage of participants
|
55.1 percentage of participants
|
55.1 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population.
The individual lesion scores were calculated individually for thickness, erythema, and scaling. Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure. The LOCF method was used for analysis.
Outcome measures
| Measure |
Vehicle Cream
n=50 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=51 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=49 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=49 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84
|
19.1 percentage of participants
|
34.7 percentage of participants
|
46.9 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population.
The individual lesion scores were calculated individually for thickness, erythema, and scaling. Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure. The LOCF method was used for analysis.
Outcome measures
| Measure |
Vehicle Cream
n=50 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=51 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=49 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=49 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84
|
42.6 percentage of participants
|
61.2 percentage of participants
|
63.3 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
The lesion areas were estimated based on the Rule of Nines method for the entire skin surface; psoriatic disease activity and the percent BSA were calculated for the treatable areas (i.e., areas that excluded the scalp, face, and intertriginous areas). The BSA is calculated as follows: BSA (m\^²)=(\[Height(cm) x Weight(kg)\]/3600 )\^½. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vehicle Cream
n=47 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=49 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=49 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=48 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA)
|
-0.36 Percent treatable BSA
Standard Deviation 2.260
|
-1.63 Percent treatable BSA
Standard Deviation 3.746
|
-2.41 Percent treatable BSA
Standard Deviation 4.276
|
-1.94 Percent treatable BSA
Standard Deviation 3.545
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 is 'Clear' (no evidence of disease) and 5 is 'very Severe' lesion. A negative change from Baseline indicates improvement. The ANCOVA method was used for analyses.
Outcome measures
| Measure |
Vehicle Cream
n=47 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=49 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=48 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=48 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score
|
-0.34 score on a scale
Standard Deviation 0.760
|
-0.73 score on a scale
Standard Deviation 0.836
|
-0.92 score on a scale
Standard Deviation 1.077
|
-0.79 score on a scale
Standard Deviation 0.922
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 indicates 'Clear' (no evidence of disease) and 5 indicates 'very Severe' lesion. A negative percent change indicates improvement. The ANCOVA method was used for analyses.
Outcome measures
| Measure |
Vehicle Cream
n=47 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=49 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=49 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=47 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Percent Change From Baseline in the PGA Score
|
-9.09 percent change from baseline
Standard Deviation 23.624
|
-22.10 percent change from baseline
Standard Deviation 24.626
|
-29.69 percent change from baseline
Standard Deviation 34.344
|
-23.33 percent change from baseline
Standard Deviation 26.485
|
SECONDARY outcome
Timeframe: Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population.
The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 indicates 'Clear' (no evidence of disease) and 5 indicates 'very Severe' lesion. Participants with individual lesion scores 0 (clear) and 1 (almost clear) are reported in this outcome measure.
Outcome measures
| Measure |
Vehicle Cream
n=50 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=51 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=49 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=49 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Clear (Score=0) and Almost Clear (Score=1) on the PGA
|
4.3 percentage of participants
|
12.2 percentage of participants
|
32.7 percentage of participants
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring \[lower extremities, trunk (including stomach, chest, back), upper extremities, head\]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area multiplied coverage for each section multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A negative change from baseline indicates improvement. The ANCOVA method was used for analyses.
Outcome measures
| Measure |
Vehicle Cream
n=47 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=49 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=49 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=48 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Absolute Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score
|
-1.49 score on a scale
Standard Deviation 2.999
|
-3.47 score on a scale
Standard Deviation 3.951
|
-3.48 score on a scale
Standard Deviation 4.204
|
-2.93 score on a scale
Standard Deviation 3.599
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 84Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number of participants analyzed are the participants with data available for analysis.
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring \[lower extremities, trunk (including stomach, chest, back), upper extremities, head\]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area multiplied by coverage for each section multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A percent negative change from baseline indicates improvement in disease. The ANCOVA method was used for analyses.
Outcome measures
| Measure |
Vehicle Cream
n=47 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=49 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=49 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=48 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Percent Change From Baseline in the PASI Score
|
-18.45 percent change
Standard Deviation 29.907
|
-34.19 percent change
Standard Deviation 40.532
|
-39.97 percent change
Standard Deviation 38.215
|
-32.81 percent change
Standard Deviation 38.995
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Days 15, 28, 56, 84, and 112Population: All participants who were randomized to treatment and had both a baseline visit and received at least one application of study drug were included in the ITT population. Overall number analyzed are the participants with percent treatable BSA of at least 10%.
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring \[lower extremities, trunk (including stomach, chest, back), upper extremities, head\]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area\* multiplied by coverage for each section\* multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A negative percent change from Baseline indicates improvement. Data for Day 84 was imputed using the LOCF method.
Outcome measures
| Measure |
Vehicle Cream
n=18 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=11 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=20 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=17 Participants
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 50% Reduction on Day 28
|
0.0 percentage of participants
|
11.1 percentage of participants
|
33.3 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 50% Reduction on Day 84
|
18.8 percentage of participants
|
60.0 percentage of participants
|
45.0 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 75% Reduction on Day 15
|
0.0 percentage of participants
|
0.0 percentage of participants
|
5.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 90% Reduction on Day 84
|
0.0 percentage of participants
|
0.0 percentage of participants
|
15.0 percentage of participants
|
6.3 percentage of participants
|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 90% Reduction on Day 112
|
0.0 percentage of participants
|
0.0 percentage of participants
|
15.8 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 50% Reduction on Day 15
|
0.0 percentage of participants
|
0.0 percentage of participants
|
20.0 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 50% Reduction on Day 56
|
16.7 percentage of participants
|
50.0 percentage of participants
|
21.1 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 50% Reduction on Day 112
|
17.6 percentage of participants
|
66.7 percentage of participants
|
31.6 percentage of participants
|
17.6 percentage of participants
|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 75% Reduction on Day 28
|
0.0 percentage of participants
|
0.0 percentage of participants
|
5.6 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 75% Reduction on Day 56
|
0.0 percentage of participants
|
25.0 percentage of participants
|
10.5 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 75% Reduction on Day 84
|
0.0 percentage of participants
|
30.0 percentage of participants
|
15.0 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 75% Reduction on Day 112
|
0.0 percentage of participants
|
33.3 percentage of participants
|
15.8 percentage of participants
|
11.8 percentage of participants
|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 90% Reduction on Day 15
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 90% Reduction on Day 28
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
Achieved 90% Reduction on Day 56
|
0.0 percentage of participants
|
0.0 percentage of participants
|
5.3 percentage of participants
|
7.7 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-application on Days 1, 15, 28, 56, and 84Population: All participants who used at least one application of study medication, and provided at least one plasma sample were considered potentially evaluable for the pharmacokinetic (PK)/ pharmacodynamic (PD) population.
Outcome measures
| Measure |
Vehicle Cream
n=51 Participants
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=49 Participants
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=49 Participants
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
|---|---|---|---|---|
|
Trough Plasma Concentrations [Minimum Concentration at Steady-state (Css,Min)] of Ruxolitinib Phosphate Prior to Study Drug Application at Steady State
|
9.19 nanomolar (nM)
Standard Deviation 11.77
|
16.99 nanomolar (nM)
Standard Deviation 19.05
|
19.97 nanomolar (nM)
Standard Deviation 25.13
|
—
|
Adverse Events
Vehicle Cream
Ruxolitinib Phosphate 0.5% Cream
Ruxolitinib Phosphate 1.0% Cream
Ruxolitinib Phosphate 1.5% Cream
Total
Serious adverse events
| Measure |
Vehicle Cream
n=50 participants at risk
Vehicle cream Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=51 participants at risk
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=49 participants at risk
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=49 participants at risk
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Total
n=199 participants at risk
Total
|
|---|---|---|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
2.0%
1/50 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/51 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/49 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/49 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.50%
1/199 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/50 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/51 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/49 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
1/49 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.50%
1/199 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/50 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
1/51 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/49 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/49 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.50%
1/199 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/50 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/51 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/49 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
1/49 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.50%
1/199 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/50 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
1/51 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/49 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/49 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.50%
1/199 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/50 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/51 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/49 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
1/49 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.50%
1/199 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/50 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/51 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/49 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
1/49 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.50%
1/199 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
Other adverse events
| Measure |
Vehicle Cream
n=50 participants at risk
Vehicle cream Vehicle cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 0.5% Cream
n=51 participants at risk
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.0% Cream
n=49 participants at risk
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
|
Ruxolitinib Phosphate 1.5% Cream
n=49 participants at risk
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
|
Total
n=199 participants at risk
Total
|
|---|---|---|---|---|---|
|
Infections and infestations
Influenza
|
4.0%
2/50 • Number of events 2 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/51 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
6.1%
3/49 • Number of events 3 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
1/49 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
3.0%
6/199 • Number of events 6 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/50 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
3.9%
2/51 • Number of events 3 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
6.1%
3/49 • Number of events 3 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
10.2%
5/49 • Number of events 5 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
5.5%
11/199 • Number of events 12 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
Infections and infestations
Sinusitis
|
2.0%
1/50 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
1/51 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
6.1%
3/49 • Number of events 3 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
4.1%
2/49 • Number of events 2 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
3.5%
7/199 • Number of events 7 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
General disorders
Application site irritation
|
6.0%
3/50 • Number of events 3 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
1/51 • Number of events 2 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
4.1%
2/49 • Number of events 2 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
10.2%
5/49 • Number of events 6 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
5.5%
11/199 • Number of events 13 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
General disorders
Application site pruritus
|
8.0%
4/50 • Number of events 5 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
3.9%
2/51 • Number of events 3 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
4.1%
2/49 • Number of events 2 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
4.1%
2/49 • Number of events 2 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
5.0%
10/199 • Number of events 12 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/50 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
5.9%
3/51 • Number of events 3 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
1/49 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
1/49 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.5%
5/199 • Number of events 5 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
Investigations
Electrocardiogram QT interval abnormal
|
0.00%
0/50 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/51 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
4.1%
2/49 • Number of events 2 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
6.1%
3/49 • Number of events 3 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.5%
5/199 • Number of events 5 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/50 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/51 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/49 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
6.1%
3/49 • Number of events 3 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
4/199 • Number of events 4 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/50 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
0.00%
0/51 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
6.1%
3/49 • Number of events 16 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
1/49 • Number of events 2 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
4/199 • Number of events 18 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
3/50 • Number of events 3 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
11.8%
6/51 • Number of events 8 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
2.0%
1/49 • Number of events 1 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
6.1%
3/49 • Number of events 3 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
6.5%
13/199 • Number of events 15 • From first dose up to 28 days after last dose of study drug (Up to 16 weeks)
Safety population included all participants who were enrolled and used at least one application of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER