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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014815-11 | EudraCT Number |
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The purpose of this study is to investigate the efficacy, safety, tolerability and the concentration/response relationship of E6201 in subjects with psoriasis vulgaris.
This is a single center, randomized, blinded, intra-individual comparison in two sequential cohorts of 15 subjects each (30 subjects in total) in an outpatient setting, in which each subject simultaneously receives five topical treatments (3 active, 1 vehicle, and 1 positive control) within one or two psoriatic plaques. Treatments consisted of 3 concentrations of E6201 gel, a negative control (gel vehicle), and a positive control (0.005% calcipotriene cream). The different concentrations of E6201 gel and vehicle control were double-blinded, while the calciprotriene cream was single-blinded. Cohort 2 participants were not dosed until all participants in Cohort 1 completed treatment and safety data were collected and evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Three concentrations of E6201 topical gel (0.03%, 0.1%, and 0.2%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. The 3 concentrations of E6201 gel were dosed first in Cohort 1 to establish the safety and tolerability prior to dosing in Cohort 2. |
|
| Cohort 2 | Experimental | Three concentrations of E6201 topical gel (0.005%, 0.01%, and 0.05%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. Cohort 2 participants were not dosed until all participants in Cohort 1 completed treatment and safety data were collected and evaluated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.03% E6201 | Drug | Topical 0.03% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate | The AUC was based on the baseline-corrected thickness of the psoriatic infiltrate (20 megahertz (MHz) Sonographic measurement) at specified days for each treatment field calculated by applying the linear trapezoidal rule. Sonographic measurements were performed using a 20 MHz high-frequency sonograph. Serial A-scans were composed and represented on a monitor as a section of the skin. A lateral resolution of approximately 200 um and an axial resolution of 80 um were possible. Dependent on the echo patterns, components of the epidermis, dermis, and subcutis were represented. Therefore, exact measurement of skin thickness was possible. The inflammatory psoriatic infiltrate was seen as a clearly definable echo lucent band below the entrance echo. The thickness of the echo lucent psoriatic band was determined. The thickness was measured in micrometers (um) and was denoted as T. | Day 0 (Baseline), Day 8 (Visit 10), and Day 12 (End of Treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Thickness of the Psoriatic Infiltrate From Baseline to End of Treatment (Day 12/Discontinuation) | Psoriatic infiltrate thickness was determined by 20 MHz Sonographic measurements using a 20 MHz high-frequency sonograph. Serial-A scans were composed and represented on a monitor as a section of the skin. A lateral resolution of approximately 200 um and an axial resolution of 80 um were possible. Dependent on the echo patterns, components of the epidermis, dermis, and subcutis were represented. Therefore exact measurement of the skin thickness was possible. The inflammatory psoriatic infiltrate was seen as a clearly definable echo lucent back below the entrance echo. The thickness of the echo lucent psoriatic band was determined. Comparisons were made with the untreated plaque(s) beneath the hydrocolloid dressing. Baseline was defined as Visit 2 (Day 0). Least Squares Means (LSM) and Confidence Intervals (CI) were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate. |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Mercer | Eisai Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioskin GmbH | Berlin | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Three concentrations of E6201 topical gel (0.03%, 0.1%, and 0.2%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site using separate tuberculin syringes that were filled with approximately 200 uL of each concentration of study treatment and comparator. Prior to each new application, remaining preparation residues were removed by gently cleansing each test field with a separate soft tissue. The fields to be treated were done in an occlusive manner for a treatment period of 12 days. Application time was to be kept as close as possible to the baseline application time, and was not to differ by more than +/- 4 hours. The 3 concentrations of E6201 gel were dosed first in Cohort 1 to establish the safety and tolerability prior to dosing in Cohort 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 0.1% E6201 | Drug | Topical 0.1% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. |
|
| 0.2% E6201 | Drug | Topical 0.2% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. |
|
| 0.005% E6201 | Drug | Topical 0.005% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. |
|
| 0.01% E6201 | Drug | Topical 0.01% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. |
|
| 0.05% E6201 | Drug | Topical 0.05% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. |
|
| Placebo - 0.03% gel vehicle | Other | Topical 0.03% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. |
|
| Placebo - 0.1% gel vehicle | Other | Topical 0.1% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. |
|
| Placebo - 0.2% gel vehicle | Other | Topical 0.2% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. |
|
| Placebo - 0.05% gel vehicle | Other | Topical 0.005% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. |
|
| Placebo - 0.01% gel vehicle | Other | Topical 0.01% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. |
|
| Placebo - 0.05% gel vehicle | Other | Topical 0.05% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. |
|
| Calcipotriene | Drug | Topical 0.005% calcipotriene (positive control) was applied once daily to individual specific regions of the psoriatic plaque. |
|
|
| Day 12/Discontinuation (Visit 14/End of Treatment) |
| Change in Thickness of the Psoriatic Infiltrate From Baseline to Day 8 | Psoriatic infiltrate thickness was determined by 20 MHz Sonographic measurements using a 20 MHz high-frequency sonograph. Serial-A scans were composed and represented on a monitor as a section of the skin. A lateral resolution of approximately 200 um and an axial resolution of 80 um were possible. Dependent on the echo patterns, components of the epidermis, dermis, and subcutis were represented. Therefore exact measurement of the skin thickness was possible. The inflammatory psoriatic infiltrate was seen as a clearly definable echo lucent back below the entrance echo. The thickness of the echo lucent psoriatic band was determined. Comparisons were made with the untreated plaque(s) beneath the hydrocolloid dressing. Baseline was defined as Visit 2 (Day 0). LSM and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate. | Day 8 (Visit 10) |
| Clinical (Global) Assessment of Efficacy at Day 12/Discontinuation | Clinical (global) assessment of the test fields was performed using a 5-point score: -1 = worsened, 0 = unchanged (no effect), 1 = slight improvement, 2 = clear improvement but not completely healed, and 3 = completely healed. Comparisons were made with the untreated plaque(s) beneath the hydrocolloid dressing. Clinically apparent differences in erythema and infiltration contributed to the global assessment. Baseline was defined as Visit 2 (Day 0). | Day 12/Discontinuation (Visit 14/End of Treatment) |
| Clinical (Global) Assessment of Efficacy on Day 8 | Clinical (global) assessment of the test fields was performed using a 5-point score: -1 = worsened, 0 = unchanged (no effect), 1 = slight improvement, 2 = clear improvement but not completely healed, and 3 = completely healed. Comparisons were made with the untreated plaque(s) beneath the hydrocolloid dressing. Clinically apparent differences in erythema and infiltration contributed to the global assessment. Baseline was defined as Visit 2 (Day 0). | Day 8 (Visit 10) |
| Overview of Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (baseline), or re-emerged during treatment, having been present at baseline but stopped prior to treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. Safety variables included TEAEs including skin reactions, diascopy and biopsy findings, clinical laboratory parameters, vital signs, and physical examinations. For Cohort 2, special attention was given to a close, daily monitoring of the application site for signs of skin irritation. Any suspected ecchymoses or petechiae were to be followed up with a diascopy test that was to be documented with digital photographs. Any positive diascopy test was to be followed up by biopsy for skin ultrastructural analysis (if agreed to by the participant, sponsor, and investigator). Few adverse events occurred in more than one treatment group. | From first dose of study treatment up to 30 days after the last dose, or until resolution, whichever came first, or up to approximately 10 months. |
| FG001 | Cohort 2 | Three concentrations of E6201 topical gel (0.005%, 0.01%, and 0.05%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described for Cohort 1. Cohort 2 participants were not dosed until all participants in Cohort 1 completed treatment and safety data were collected and evaluated. |
| COMPLETED |
|
| NOT COMPLETED |
|
Safety population included all participants who received at least one application of at least one study treatment and had at least one postdose safety assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Three concentrations of E6201 topical gel (0.03%, 0.1%, and 0.2%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site using separate tuberculin syringes that were filled with approximately 200 uL of each concentration of study treatment and comparator. Prior to each new application, remaining preparation residues were removed by gently cleansing each test field with a separate soft tissue. The fields to be treated were done in an occlusive manner for a treatment period of 12 days. Application time was to be kept as close as possible to the baseline application time, and was not to differ by more than +/- 4 hours. The 3 concentrations of E6201 gel were dosed first in Cohort 1 to establish the safety and tolerability prior to dosing in Cohort 2. |
| BG001 | Cohort 2 | Three concentrations of E6201 topical gel (0.005%, 0.01%, and 0.05%) and active comparator, calcipotriene cream (0.005%), were applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described for Cohort 1. Cohort 2 participants were not dosed until all participants in Cohort 1 completed treatment and safety data were collected and evaluated. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Geometric Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate | The AUC was based on the baseline-corrected thickness of the psoriatic infiltrate (20 megahertz (MHz) Sonographic measurement) at specified days for each treatment field calculated by applying the linear trapezoidal rule. Sonographic measurements were performed using a 20 MHz high-frequency sonograph. Serial A-scans were composed and represented on a monitor as a section of the skin. A lateral resolution of approximately 200 um and an axial resolution of 80 um were possible. Dependent on the echo patterns, components of the epidermis, dermis, and subcutis were represented. Therefore, exact measurement of skin thickness was possible. The inflammatory psoriatic infiltrate was seen as a clearly definable echo lucent band below the entrance echo. The thickness of the echo lucent psoriatic band was determined. The thickness was measured in micrometers (um) and was denoted as T. | Full analysis population (Intent-to-treat population) included all randomized participants who received at least one application of at least one study treatment and had at least one postbaseline efficacy assessment. | Posted | Least Squares Mean | 95% Confidence Interval | um.day | Day 0 (Baseline), Day 8 (Visit 10), and Day 12 (End of Treatment) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Thickness of the Psoriatic Infiltrate From Baseline to End of Treatment (Day 12/Discontinuation) | Psoriatic infiltrate thickness was determined by 20 MHz Sonographic measurements using a 20 MHz high-frequency sonograph. Serial-A scans were composed and represented on a monitor as a section of the skin. A lateral resolution of approximately 200 um and an axial resolution of 80 um were possible. Dependent on the echo patterns, components of the epidermis, dermis, and subcutis were represented. Therefore exact measurement of the skin thickness was possible. The inflammatory psoriatic infiltrate was seen as a clearly definable echo lucent back below the entrance echo. The thickness of the echo lucent psoriatic band was determined. Comparisons were made with the untreated plaque(s) beneath the hydrocolloid dressing. Baseline was defined as Visit 2 (Day 0). Least Squares Means (LSM) and Confidence Intervals (CI) were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate. | Full analysis population (Intent-to-treat population) included all randomized participants who received at least one application of at least one study treatment and had at least one postbaseline efficacy assessment. | Posted | Least Squares Mean | 95% Confidence Interval | um | Day 12/Discontinuation (Visit 14/End of Treatment) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Thickness of the Psoriatic Infiltrate From Baseline to Day 8 | Psoriatic infiltrate thickness was determined by 20 MHz Sonographic measurements using a 20 MHz high-frequency sonograph. Serial-A scans were composed and represented on a monitor as a section of the skin. A lateral resolution of approximately 200 um and an axial resolution of 80 um were possible. Dependent on the echo patterns, components of the epidermis, dermis, and subcutis were represented. Therefore exact measurement of the skin thickness was possible. The inflammatory psoriatic infiltrate was seen as a clearly definable echo lucent back below the entrance echo. The thickness of the echo lucent psoriatic band was determined. Comparisons were made with the untreated plaque(s) beneath the hydrocolloid dressing. Baseline was defined as Visit 2 (Day 0). LSM and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate. | Full analysis population (Intent-to-treat population) included all randomized participants who received at least one application of at least one study treatment and had at least one postbaseline efficacy assessment. | Posted | Least Squares Mean | 95% Confidence Interval | um | Day 8 (Visit 10) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical (Global) Assessment of Efficacy at Day 12/Discontinuation | Clinical (global) assessment of the test fields was performed using a 5-point score: -1 = worsened, 0 = unchanged (no effect), 1 = slight improvement, 2 = clear improvement but not completely healed, and 3 = completely healed. Comparisons were made with the untreated plaque(s) beneath the hydrocolloid dressing. Clinically apparent differences in erythema and infiltration contributed to the global assessment. Baseline was defined as Visit 2 (Day 0). | Full analysis population (Intent-to-treat population) included all randomized participants who received at least one application of at least one study treatment and had at least one postbaseline efficacy assessment. | Posted | Number | Percentage of participants | Day 12/Discontinuation (Visit 14/End of Treatment) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical (Global) Assessment of Efficacy on Day 8 | Clinical (global) assessment of the test fields was performed using a 5-point score: -1 = worsened, 0 = unchanged (no effect), 1 = slight improvement, 2 = clear improvement but not completely healed, and 3 = completely healed. Comparisons were made with the untreated plaque(s) beneath the hydrocolloid dressing. Clinically apparent differences in erythema and infiltration contributed to the global assessment. Baseline was defined as Visit 2 (Day 0). | Full analysis population (Intent-to-treat population) included all randomized participants who received at least one application of at least one study treatment and had at least one postbaseline efficacy assessment. | Posted | Number | Percentage of participants | Day 8 (Visit 10) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overview of Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (baseline), or re-emerged during treatment, having been present at baseline but stopped prior to treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. Safety variables included TEAEs including skin reactions, diascopy and biopsy findings, clinical laboratory parameters, vital signs, and physical examinations. For Cohort 2, special attention was given to a close, daily monitoring of the application site for signs of skin irritation. Any suspected ecchymoses or petechiae were to be followed up with a diascopy test that was to be documented with digital photographs. Any positive diascopy test was to be followed up by biopsy for skin ultrastructural analysis (if agreed to by the participant, sponsor, and investigator). Few adverse events occurred in more than one treatment group. | Safety population included all participants who received at least one application of at least one study treatment and had at least one postdose safety assessment. | Posted | Number | Percentage of participants | From first dose of study treatment up to 30 days after the last dose, or until resolution, whichever came first, or up to approximately 10 months. |
|
From first dose of study treatment up to 30 days after the last dose, or until resolution, whichever came first, or up to approximately 10 months.
Treatment-emergent adverse events (TEAEs) were collected and defined as an AE that emerged during treatment, having been absent at pretreatment, or re-emerged during treatment, having been present at baseline but stopped prior to treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. Few adverse events occurred in more than one treatment group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daivonex (Calcipotriene Cream) | Daivonex (calcipotriene cream) at 0.005% was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site using a tuberculin syringe that was filled with approximately 200 uL of Daivonex. Prior to each new application, remaining preparation residues were removed by gently cleansing each test field with a separate soft tissue. The fields to be treated were done in an occlusive manner for a treatment period of 12 days. Application time was to be kept as close as possible to the baseline application time, and was not to differ by more than +/- 4 hours. | 0 | 30 | 0 | 30 | 3 | 30 |
| EG001 | E6201 Vehicle | E6201 vehicle was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. | 0 | 30 | 0 | 30 | 1 | 30 |
| EG002 | 0.005% E6201 Gel | E6201 gel (0.005%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | 0.01% E6201 Gel | E6201 gel (0.01%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG004 | 0.03% E6201 Gel | E6201 gel (0.03%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. | 0 | 15 | 0 | 15 | 4 | 15 |
| EG005 | 0.05% E6201 Gel | E6201 gel (0.05%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. | 0 | 15 | 0 | 15 | 5 | 15 |
| EG006 | 0.1% E6201 Gel | E6201 gel (0.1%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG007 | 0.2% E6201 Gel | E6201 gel (0.2%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. | 0 | 6 | 0 | 6 | 6 | 6 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Lividity | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Medical Research Inc. | 1-888-274-2378 | esi_medinfo@eisai.com |
| ID | Term |
|---|---|
| C545120 | 14-(ethylamino)-8,9,16-trihydroxy-3,4-dimethyl-3,4,9,19-tetrahydro-1H-2-benzoxacyclotetradecine-1,7(8H)-dione |
| D005782 | Gels |
| C055085 | calcipotriene |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| OG005 | 0.05% E6201 Gel | E6201 gel (0.05%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG006 | 0.1% E6201 Gel | E6201 gel (0.1%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG007 | 0.2% E6201 Gel | E6201 gel (0.2%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate. |
| ANCOVA |
| <0.0001 |
| Difference in LSM (vehicle - E6201 gel) |
| 1119.8 |
| 2-Sided |
| 95 |
| 858.9 |
| 1380.6 |
| Superiority |
| The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate. | ANCOVA | 0.0523 | Difference in LSM (vehicle - E6201 gel) | 780.0 | 2-Sided | 95 | -8.5 | 1568.5 | Superiority |
| The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate. | ANCOVA | <0.0001 | Difference in LSM (vehicle - E6201 gel) | 1775.1 | 2-Sided | 95 | 1392.3 | 2158.0 | Superiority |
| The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate. | ANCOVA | 0.0002 | Difference in LSM (vehicle - E6201 gel) | 921.4 | 2-Sided | 95 | 515.7 | 1327.1 | Superiority |
| The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate. | ANCOVA | 0.0115 | Difference in LSM (vehicle - E6201 gel) | 937.8 | 2-Sided | 95 | 267.6 | 1607.9 | Superiority |
| OG001 | E6201 Vehicle | E6201-vehicle was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG002 | 0.005% E6201 Gel | E6201 gel (0.005%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG003 | 0.01% E6201 Gel | E6201 gel (0.01%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG004 | 0.03% E6201 Gel | E6201 gel (0.03%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG005 | 0.05% E6201 Gel | E6201 gel (0.05%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG006 | 0.1% E6201 Gel | E6201 gel (0.1%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG007 | 0.2% E6201 Gel | E6201 gel (0.2%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
|
|
|
| OG001 | E6201 Vehicle | E6201-vehicle was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG002 | 0.005% E6201 Gel | E6201 gel (0.005%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG003 | 0.01% E6201 Gel | E6201 gel (0.01%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG004 | 0.03% E6201 Gel | E6201 gel (0.03%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG005 | 0.05% E6201 Gel | E6201 gel (0.05%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG006 | 0.1% E6201 Gel | E6201 gel (0.1%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG007 | 0.2% E6201 Gel | E6201 gel (0.2%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
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| E6201 Vehicle |
E6201-vehicle was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG002 | 0.005% E6201 Gel | E6201 gel (0.005%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG003 | 0.01% E6201 Gel | E6201 gel (0.01%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG004 | 0.03% E6201 Gel | E6201 gel (0.03%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG005 | 0.05% E6201 Gel | E6201 gel (0.05%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG006 | 0.1% E6201 Gel | E6201 gel (0.1%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG007 | 0.2% E6201 Gel | E6201 gel (0.2%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
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E6201-vehicle was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG002 | 0.005% E6201 Gel | E6201 gel (0.005%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG003 | 0.01% E6201 Gel | E6201 gel (0.01%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG004 | 0.03% E6201 Gel | E6201 gel (0.03%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG005 | 0.05% E6201 Gel | E6201 gel (0.05%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG006 | 0.1% E6201 Gel | E6201 gel (0.1%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG007 | 0.2% E6201 Gel | E6201 gel (0.2%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
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| OG001 | E6201 Vehicle | E6201 vehicle was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG002 | 0.005% E6201 Gel | E6201 gel (0.005%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG003 | 0.01% E6201 Gel | E6201 gel (0.01%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG004 | 0.03% E6201 Gel | E6201 gel (0.03%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG005 | 0.05% E6201 Gel | E6201 gel (0.05%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG006 | 0.1% E6201 Gel | E6201 gel (0.1%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
| OG007 | 0.2% E6201 Gel | E6201 gel (0.2%) was applied once daily for 12 days to specific test fields determined at Baseline. Study treatments were applied at the research unit by designated personnel of the investigational site in the same manner as described earlier. |
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