Psoriasis
Conditions
Keywords
psoriasis
Brief summary
This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.
Interventions
DRUGRuxolitinib
Ruxolitinib 1.5% cream BID for 28 days
Sponsors
Incyte Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have psoriatic lesions measuring protocol specific BSA
Exclusion criteria
* Lesions solely involving the palms of the hands, the soles of the feet, the intertriginious areas, the scalp or the face * Pustular psoriasis or erythroderma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment of Emergent Adverse Events | Approximately 3 months | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment |
| Pharmacokinetics Parameter : Skin Flux of INCB018424 | Days 1, 4, 8, 15, 22, and 28-30 | The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. |
| Pharmacokinetics Parameter: Bioavailability of INCB018424 | Approximately one month: Days 1, 4, 8, 15, 22, and 28 | The INCB018424 bioavailability was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. |
| Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424 | Approximately one month: Days 1, 4, 8, 15, 22, and 28 | All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Psoriatic Lesion Area | Days 1 and 28 | The target and control lesion areas were determined in an objective manner on Day 1 and Day 28 based on a tracing of the perimeter of the lesions on transparency film and measurement of the area. |
| Mean Change in Physicians Global Assessment Score | Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later | The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a scale that ranged from 0 (clear) to 6 (most severe) in whole-unit increments. Note that, for analysis purposes, the scale was adjusted to range from 1 (clear) to 7 (most severe) to allow for the evaluation of mean scores. |
| Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up) | Changes in total lesion scores were compared to baseline score. Lesions were compared between active treated areas INCB018424 and control areas of the same subject (within-subject comparisons) using one sample t-test. Total lesion score was calculated as the sum of the scores for Thickness (T), erythema (E), and scaling (S) for the target and control lesions. All individual scores use a 5-point scale ranging from 0 (none) to 4 (severe) with increasing score reflecting increased lesion severity. These ratings are then added to create a total score ranging from 0 to 12. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 6 study centers in the United States from 08 November 2007 to 13 April 2009. This study is completed.
Pre-assignment details
A total of 25 participants with active but stable plaque psoriasis were enrolled in the dose-escalation study.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A 2% to 7% of BSA treated BID with INCB018424 1.5% cream | 5 |
| Cohort B 8% to 13% of BSA treated BID with INCB018424 1.5% cream | 5 |
| Cohort C 14% to 20% of BSA treated QD with INCB018424 1.5% cream | 5 |
| Cohort D 14% to 20% of BSA treated BID with INCB018424 1.0% cream | 5 |
| Cohort E 14% to 20% of BSA treated BID with INCB018424 1.5% cream | 5 |
| Total | 25 |
Baseline characteristics
| Characteristic | Cohort A | Cohort B | Cohort C | Cohort D | Cohort E | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 37.8 Years STANDARD_DEVIATION 6.22 | 32.4 Years STANDARD_DEVIATION 7.57 | 43.2 Years STANDARD_DEVIATION 13.94 | 46.2 Years STANDARD_DEVIATION 12.21 | 42.8 Years STANDARD_DEVIATION 18.16 | 40.5 Years STANDARD_DEVIATION 12.36 |
| Race/Ethnicity, Customized American Indian/Alaskan Native White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 4 Participants | 4 Participants | 4 Participants | 5 Participants | 4 Participants | 21 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White or Caucasian | 4 Participants | 5 Participants | 5 Participants | 5 Participants | 3 Participants | 22 Participants |
| Sex/Gender, Customized Female | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 5 Participants |
| Sex/Gender, Customized Male | 5 Participants | 3 Participants | 4 Participants | 4 Participants | 4 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 25 |
| other Total, other adverse events | 2 / 5 | 4 / 5 | 2 / 5 | 1 / 5 | 2 / 5 | 11 / 25 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 1 / 5 | 0 / 5 | 0 / 5 | 1 / 25 |
Outcome results
Primary
Number of Treatment of Emergent Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Time frame: Approximately 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A | Number of Treatment of Emergent Adverse Events | 2 Participants |
| Cohort B | Number of Treatment of Emergent Adverse Events | 4 Participants |
| Cohort C | Number of Treatment of Emergent Adverse Events | 2 Participants |
| Cohort D | Number of Treatment of Emergent Adverse Events | 1 Participants |
| Cohort E | Number of Treatment of Emergent Adverse Events | 2 Participants |
Primary
Pharmacokinetics Parameter: Bioavailability of INCB018424
The INCB018424 bioavailability was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.
Time frame: Approximately one month: Days 1, 4, 8, 15, 22, and 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A | Pharmacokinetics Parameter: Bioavailability of INCB018424 | 3.8 percentage | Standard Deviation 2.5 |
| Cohort B | Pharmacokinetics Parameter: Bioavailability of INCB018424 | 4.1 percentage | Standard Deviation 3.4 |
| Cohort C | Pharmacokinetics Parameter: Bioavailability of INCB018424 | 3.4 percentage | Standard Deviation 1.9 |
| Cohort D | Pharmacokinetics Parameter: Bioavailability of INCB018424 | 3.9 percentage | Standard Deviation 1.3 |
| Cohort E | Pharmacokinetics Parameter: Bioavailability of INCB018424 | 5.2 percentage | Standard Deviation 1.9 |
Primary
Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424
All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose.
Time frame: Approximately one month: Days 1, 4, 8, 15, 22, and 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A | Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424 | 7.00 nM | Standard Deviation 2.1 |
| Cohort B | Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424 | 28.38 nM | Standard Deviation 13.1 |
| Cohort C | Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424 | 24.41 nM | Standard Deviation 10.07 |
| Cohort D | Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424 | 34.97 nM | Standard Deviation 20.44 |
| Cohort E | Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424 | 60.98 nM | Standard Deviation 73.85 |
Primary
Pharmacokinetics Parameter : Skin Flux of INCB018424
The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.
Time frame: Days 1, 4, 8, 15, 22, and 28-30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A | Pharmacokinetics Parameter : Skin Flux of INCB018424 | 180 ng/cm^2/h | Standard Deviation 126 |
| Cohort B | Pharmacokinetics Parameter : Skin Flux of INCB018424 | 131 ng/cm^2/h | Standard Deviation 92 |
| Cohort C | Pharmacokinetics Parameter : Skin Flux of INCB018424 | 60 ng/cm^2/h | Standard Deviation 43 |
| Cohort D | Pharmacokinetics Parameter : Skin Flux of INCB018424 | 151 ng/cm^2/h | Standard Deviation 126 |
| Cohort E | Pharmacokinetics Parameter : Skin Flux of INCB018424 | 152 ng/cm^2/h | Standard Deviation 74 |
Secondary
Mean Change in Physicians Global Assessment Score
The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a scale that ranged from 0 (clear) to 6 (most severe) in whole-unit increments. Note that, for analysis purposes, the scale was adjusted to range from 1 (clear) to 7 (most severe) to allow for the evaluation of mean scores.
Time frame: Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Mean Change in Physicians Global Assessment Score | Day 15 | 2.6 Score | Standard Deviation 0.55 |
| Cohort A | Mean Change in Physicians Global Assessment Score | Follow-up | 3.4 Score | Standard Deviation 0.89 |
| Cohort A | Mean Change in Physicians Global Assessment Score | Screening | 4.4 Score | Standard Deviation 0.55 |
| Cohort A | Mean Change in Physicians Global Assessment Score | Day 22 | 2.4 Score | Standard Deviation 0.55 |
| Cohort A | Mean Change in Physicians Global Assessment Score | Day 8 | 3.4 Score | Standard Deviation 0.55 |
| Cohort A | Mean Change in Physicians Global Assessment Score | Day 28 | 2.4 Score | Standard Deviation 0.55 |
| Cohort A | Mean Change in Physicians Global Assessment Score | Day 1 | 4.0 Score | Standard Deviation 0 |
| Cohort B | Mean Change in Physicians Global Assessment Score | Follow-up | 3.4 Score | Standard Deviation 0.89 |
| Cohort B | Mean Change in Physicians Global Assessment Score | Day 22 | 3.0 Score | Standard Deviation 0.71 |
| Cohort B | Mean Change in Physicians Global Assessment Score | Day 28 | 2.6 Score | Standard Deviation 0.89 |
| Cohort B | Mean Change in Physicians Global Assessment Score | Day 1 | 4.4 Score | Standard Deviation 0.89 |
| Cohort B | Mean Change in Physicians Global Assessment Score | Screening | 4.4 Score | Standard Deviation 0.89 |
| Cohort B | Mean Change in Physicians Global Assessment Score | Day 8 | 3.6 Score | Standard Deviation 0.55 |
| Cohort B | Mean Change in Physicians Global Assessment Score | Day 15 | 3.2 Score | Standard Deviation 0.84 |
| Cohort C | Mean Change in Physicians Global Assessment Score | Screening | 4.2 Score | Standard Deviation 0.45 |
| Cohort C | Mean Change in Physicians Global Assessment Score | Day 1 | 4.2 Score | Standard Deviation 0.45 |
| Cohort C | Mean Change in Physicians Global Assessment Score | Follow-up | 3.2 Score | Standard Deviation 1.3 |
| Cohort C | Mean Change in Physicians Global Assessment Score | Day 28 | 3.4 Score | Standard Deviation 0.55 |
| Cohort C | Mean Change in Physicians Global Assessment Score | Day 15 | 3.8 Score | Standard Deviation 0.84 |
| Cohort C | Mean Change in Physicians Global Assessment Score | Day 22 | 3.6 Score | Standard Deviation 0.89 |
| Cohort C | Mean Change in Physicians Global Assessment Score | Day 8 | 4.0 Score | Standard Deviation 0.71 |
| Cohort D | Mean Change in Physicians Global Assessment Score | Follow-up | 4.0 Score | Standard Deviation 0.71 |
| Cohort D | Mean Change in Physicians Global Assessment Score | Screening | 4.4 Score | Standard Deviation 0.55 |
| Cohort D | Mean Change in Physicians Global Assessment Score | Day 1 | 4.4 Score | Standard Deviation 0.55 |
| Cohort D | Mean Change in Physicians Global Assessment Score | Day 8 | 4.2 Score | Standard Deviation 0.45 |
| Cohort D | Mean Change in Physicians Global Assessment Score | Day 15 | 3.8 Score | Standard Deviation 0.45 |
| Cohort D | Mean Change in Physicians Global Assessment Score | Day 22 | 3.2 Score | Standard Deviation 0.45 |
| Cohort D | Mean Change in Physicians Global Assessment Score | Day 28 | 3.0 Score | Standard Deviation 0.71 |
| Cohort E | Mean Change in Physicians Global Assessment Score | Day 15 | 2.6 Score | Standard Deviation 0.55 |
| Cohort E | Mean Change in Physicians Global Assessment Score | Follow-up | 3.2 Score | Standard Deviation 0.45 |
| Cohort E | Mean Change in Physicians Global Assessment Score | Day 28 | 2.4 Score | Standard Deviation 0.55 |
| Cohort E | Mean Change in Physicians Global Assessment Score | Day 8 | 3.0 Score | Standard Deviation 0 |
| Cohort E | Mean Change in Physicians Global Assessment Score | Day 1 | 4.0 Score | Standard Deviation 0 |
| Cohort E | Mean Change in Physicians Global Assessment Score | Screening | 4.0 Score | Standard Deviation 0 |
| Cohort E | Mean Change in Physicians Global Assessment Score | Day 22 | 2.6 Score | Standard Deviation 0.55 |
Secondary
Mean Change in Psoriatic Lesion Area
The target and control lesion areas were determined in an objective manner on Day 1 and Day 28 based on a tracing of the perimeter of the lesions on transparency film and measurement of the area.
Time frame: Days 1 and 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A | Mean Change in Psoriatic Lesion Area | -2.20 cm^2 | Standard Deviation 23.993 |
| Cohort B | Mean Change in Psoriatic Lesion Area | -237.76 cm^2 | Standard Deviation 240.5 |
| Cohort C | Mean Change in Psoriatic Lesion Area | -15.94 cm^2 | Standard Deviation 38.247 |
| Cohort D | Mean Change in Psoriatic Lesion Area | -620.56 cm^2 | Standard Deviation 714.829 |
| Cohort E | Mean Change in Psoriatic Lesion Area | 0.40 cm^2 | Standard Deviation 11.336 |
| Cohort C | Mean Change in Psoriatic Lesion Area | -1267.78 cm^2 | Standard Deviation 1009.159 |
| Cohort D: Control Lesion | Mean Change in Psoriatic Lesion Area | -9.02 cm^2 | Standard Deviation 10.346 |
| Cohort D | Mean Change in Psoriatic Lesion Area | -871.12 cm^2 | Standard Deviation 1062.346 |
| Cohort E: Control Lesion | Mean Change in Psoriatic Lesion Area | -12.32 cm^2 | Standard Deviation 23.283 |
| Cohort E | Mean Change in Psoriatic Lesion Area | -823.78 cm^2 | Standard Deviation 313.733 |
Secondary
Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline
Changes in total lesion scores were compared to baseline score. Lesions were compared between active treated areas INCB018424 and control areas of the same subject (within-subject comparisons) using one sample t-test. Total lesion score was calculated as the sum of the scores for Thickness (T), erythema (E), and scaling (S) for the target and control lesions. All individual scores use a 5-point scale ranging from 0 (none) to 4 (severe) with increasing score reflecting increased lesion severity. These ratings are then added to create a total score ranging from 0 to 12.
Time frame: Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cohort A | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 28 | 0.8 Change in Total Score |
| Cohort A | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Follow-up | 1.2 Change in Total Score |
| Cohort A | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 8 | .4 Change in Total Score |
| Cohort A | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 22 | 1.0 Change in Total Score |
| Cohort A | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 15 | 0.2 Change in Total Score |
| Cohort B | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Follow-up | -1.2 Change in Total Score |
| Cohort B | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 15 | -3.2 Change in Total Score |
| Cohort B | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 22 | -2.8 Change in Total Score |
| Cohort B | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 8 | -1.4 Change in Total Score |
| Cohort B | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 28 | -3.4 Change in Total Score |
| Cohort C | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 15 | -2.00 Change in Total Score |
| Cohort C | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Follow-up | 1.0 Change in Total Score |
| Cohort C | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 8 | -0.8 Change in Total Score |
| Cohort C | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 28 | -2.0 Change in Total Score |
| Cohort C | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 22 | -1.8 Change in Total Score |
| Cohort D | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 28 | -5.4 Change in Total Score |
| Cohort D | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 8 | -4.0 Change in Total Score |
| Cohort D | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Follow-up | -3.6 Change in Total Score |
| Cohort D | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 15 | -4.2 Change in Total Score |
| Cohort D | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 22 | -5.0 Change in Total Score |
| Cohort E | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 15 | -0.6 Change in Total Score |
| Cohort E | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Follow-up | -4.2 Change in Total Score |
| Cohort E | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 28 | -3.6 Change in Total Score |
| Cohort E | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 8 | -0.2 Change in Total Score |
| Cohort E | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 22 | -2.8 Change in Total Score |
| Cohort C | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 22 | -3.6 Change in Total Score |
| Cohort C | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 8 | -1.2 Change in Total Score |
| Cohort C | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 15 | -2.6 Change in Total Score |
| Cohort C | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 28 | -4.4 Change in Total Score |
| Cohort C | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Follow-up | -3.2 Change in Total Score |
| Cohort D: Control Lesion | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 15 | 0.8 Change in Total Score |
| Cohort D: Control Lesion | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 28 | 0.6 Change in Total Score |
| Cohort D: Control Lesion | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Follow-up | 0.6 Change in Total Score |
| Cohort D: Control Lesion | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 8 | -0.2 Change in Total Score |
| Cohort D: Control Lesion | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 22 | 1.0 Change in Total Score |
| Cohort D | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 22 | -2.8 Change in Total Score |
| Cohort D | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 15 | -0.8 Change in Total Score |
| Cohort D | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 28 | -3.6 Change in Total Score |
| Cohort D | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 8 | -1.2 Change in Total Score |
| Cohort D | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Follow-up | -1.0 Change in Total Score |
| Cohort E: Control Lesion | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 8 | 0.2 Change in Total Score |
| Cohort E: Control Lesion | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 22 | -0.4 Change in Total Score |
| Cohort E: Control Lesion | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 15 | -0.8 Change in Total Score |
| Cohort E: Control Lesion | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 28 | -1.2 Change in Total Score |
| Cohort E: Control Lesion | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Follow-up | -2.0 Change in Total Score |
| Cohort E | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 28 | -3.8 Change in Total Score |
| Cohort E | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 8 | -2.8 Change in Total Score |
| Cohort E | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Follow-up | -2.8 Change in Total Score |
| Cohort E | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 15 | -3.6 Change in Total Score |
| Cohort E | Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | Day 22 | -3.6 Change in Total Score |