Trial · NCT01268527
A 12-Day Randomized, Blinded, Vehicle and Active Comparator-Controlled Study to Determine the Efficacy and Safety of Six Concentrations of Topical E6201 Gel in Subjects With Psoriasis Vulgaris
NCT01268527, Phase 2, Completed, Eisai Limited; results first posted 2021-06-11
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A 12-Day Randomized, Blinded, Vehicle and Active Comparator-Controlled Study to Determine the Efficacy and Safety of Six Concentrations of Topical E6201 Gel in Subjects With Psoriasis Vulgaris. Trials, record NCT01268527. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01268527
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 12-Day Randomized, Blinded, Vehicle and Active Comparator-Controlled Study to Determine the Efficacy and Safety of Six Concentrations of Topical E6201 Gel in Subjects With Psoriasis Vulgaris
- NCT number
- NCT01268527
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Eisai Limited
- Conditions
- Psoriasis Vulgaris
- Interventions
0.03% E6201, 0.1% E6201, 0.2% E6201, 0.005% E6201, 0.01% E6201, 0.05% E6201, Placebo - 0.03% gel vehicle, Placebo - 0.1% gel vehicle, Placebo - 0.2% gel vehicle, Placebo - 0.05% gel vehicle, Placebo - 0.01% gel vehicle, Placebo - 0.05% gel vehicle, Calcipotriene
- First posted
- 2010-12-31
- Last updated
- 2021-06-11
- Other registries' IDs
- eudract:2009-014815-11
- Results first posted
- 2021-06-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate | Day 0 (Baseline), Day 8 (Visit 10), and Day 12 (End of Treatment) | 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. |
| Secondary | Change in Thickness of the Psoriatic Infiltrate From Baseline to End of Treatment (Day 12/Discontinuation) | Day 12/Discontinuation (Visit 14/End of Treatment) | 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. |
| Secondary | Change in Thickness of the Psoriatic Infiltrate From Baseline to Day 8 | Day 8 (Visit 10) | 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. |
| Secondary | Clinical (Global) Assessment of Efficacy at Day 12/Discontinuation | Day 12/Discontinuation (Visit 14/End of Treatment) | 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). |
| Secondary | Clinical (Global) Assessment of Efficacy on Day 8 | Day 8 (Visit 10) | 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). |
| Secondary | Overview of Treatment-Emergent Adverse Events (TEAEs) | 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. | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate | Day 0 (Baseline), Day 8 (Visit 10), and Day 12 (End of Treatment) | 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. | um.day | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Thickness of the Psoriatic Infiltrate From Baseline to End of Treatment (Day 12/Discontinuation) | Day 12/Discontinuation (Visit 14/End of Treatment) | 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. | um | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Thickness of the Psoriatic Infiltrate From Baseline to Day 8 | Day 8 (Visit 10) | 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. | um | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical (Global) Assessment of Efficacy at Day 12/Discontinuation | Day 12/Discontinuation (Visit 14/End of Treatment) | 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. | Percentage of participants | NUMBER |
| SECONDARY | Clinical (Global) Assessment of Efficacy on Day 8 | Day 8 (Visit 10) | 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. | Percentage of participants | NUMBER |
| SECONDARY | Overview of Treatment-Emergent Adverse Events (TEAEs) | 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. | 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. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group160
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate | Daivonex (Calcipotriene Cream) | -1449.2 | 95% Confidence Interval -1660.0 to -1238.4 | um.day | |
| Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate | E6201 Vehicle | 17.0 | 95% Confidence Interval -64.3 to 98.3 | um.day | |
| Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate | 0.005% E6201 Gel | -694.4 | 95% Confidence Interval -1108.0 to -280.8 | um.day | |
| Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate | 0.01% E6201 Gel | -1102.8 | 95% Confidence Interval -1351.8 to -853.8 | um.day | |
| Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate | 0.03% E6201 Gel | -763.1 | 95% Confidence Interval -1548.2 to 22.1 | um.day | |
| Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate | 0.05% E6201 Gel | -1758.2 | 95% Confidence Interval -2134.3 to -1382.1 | um.day | |
| Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate | 0.1% E6201 Gel | -904.4 | 95% Confidence Interval -1303.4 to -505.4 | um.day | |
| Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate | 0.2% E6201 Gel | -920.8 | 95% Confidence Interval -1588.3 to -253.3 | um.day | |
| Change in Thickness of the Psoriatic Infiltrate From Baseline to End of Treatment (Day 12/Discontinuation) | Daivonex (Calcipotriene Cream) | -205.3 | 95% Confidence Interval -239.2 to -171.4 | um | |
| Change in Thickness of the Psoriatic Infiltrate From Baseline to End of Treatment (Day 12/Discontinuation) | E6201 Vehicle | 7.1 | 95% Confidence Interval -32.2 to 46.3 | um |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 15 | |
| Overall Study | STARTED | Cohort 2 | 15 | |
| Overall Study | COMPLETED | Cohort 1 | 15 | |
| Overall Study | COMPLETED | Cohort 2 | 15 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 0 |
Source ClinicalTrials.gov
Adverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Daivonex (Calcipotriene Cream) | 0 | 30 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | E6201 Vehicle | 0 | 30 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | 0.005% E6201 Gel | 0 | 15 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | 0.01% E6201 Gel | 0 | 15 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | 0.03% E6201 Gel | 0 | 15 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | 0.05% E6201 Gel | 0 | 15 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | 0.1% E6201 Gel | 1 | 6 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | 0.2% E6201 Gel | 1 | 6 | |
| other | Rash erythematous | Skin and subcutaneous tissue disorders | Daivonex (Calcipotriene Cream) | 2 | 30 | |
| other | Rash erythematous | Skin and subcutaneous tissue disorders | E6201 Vehicle | 0 | 30 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daivonex (Calcipotriene Cream) | 0 | 30 |
| Total, all-cause mortality | E6201 Vehicle | 0 | 30 |
| Total, all-cause mortality | 0.005% E6201 Gel | 0 | 15 |
| Total, all-cause mortality | 0.01% E6201 Gel | 0 | 15 |
| Total, all-cause mortality | 0.03% E6201 Gel | 0 | 15 |
| Total, all-cause mortality | 0.05% E6201 Gel | 0 | 15 |
| Total, all-cause mortality | 0.1% E6201 Gel | 0 | 6 |
| Total, all-cause mortality | 0.2% E6201 Gel | 0 | 6 |
| Total, other adverse events | Daivonex (Calcipotriene Cream) | 3 | 30 |
| Total, other adverse events | E6201 Vehicle | 1 | 30 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01268527
GET https://conductscience.org/api/trials/v1/NCT01268527/results?page=2