Psoriasis VulgarisPhase 2NCT01268527
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
A Phase 2 study testing 0.03% E6201, 0.1% E6201 and 0.2% E6201 in people with Psoriasis Vulgaris, run by Eisai Limited at 1 site in Germany.
Trial summary
The purpose of this study is to investigate the efficacy, safety, tolerability and the concentration/response relationship of E6201 in subjects with psoriasis vulgaris. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- 0.03% E6201, 0.1% E6201 and 0.2% E6201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2010to 11 Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stable plaque psoriasis with one or two stable psoriatic plaques(s) suitable in size and location for five separate treatment fields to be assessed within it.
- Males and females aged between 18 and 75 years of age
- The general physical examination should be normal (excluding the skin examination for psoriasis) unless the Investigator considers an abnormality not to be clinically significant with regard to the study
- Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin at Visit 1 (Screening) and a negative urine pregnancy test prior to starting study drug(s) (Visit 2). Female subjects of childbearing potential must agree to be abstinent or to use a highly effective method of contraception throughout the study period and for 30 days after the last dose of study drug.
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
Who cannot join
- Any clinically significant skin diseases other then chronic stable plaque psoriasis
- Other types of psoriasis than chronic stable plaque variant eg, guttate, pustular, erythodermic, etc
- An unstable course of the disease defined as flare(s) in the previous month
- Subjects who used any concommitant topical treatment for the psoriatic plaque(s) to be studied (other than emollients or salicylic acid) within 8 weeks before the Baseline visit eg corticosteroids or topical immunomodulators, anthralin (dithranil), vitamin D derivatives, ultraviolet-light therapy including sunbathing , or retinoids.
- Subjects who used any of the following systemic treatments within 12 weeks before the Baseline visit eg: corticosteroids or adrenocorticotrophic hormone analogs, retinoids such as acitretin or isotretinoin, cyclosporin, interferon, methotrexate, other immuno-suppressive/immunomodulating drugs, psoralen and ultraviolet A therapy, or biologics
- Subjects planning on significant exposure to sun (sun-bathing)
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- Treatment with systemic or locally acting medications which might counter or influence the study aim (eg monoamine oxidase inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, eg Beta-blockers, antimalarial drugs, and lithium within two weeks before the Baseline visit
- Subject is a dependent person, ie, a relative/family member of the Investigator and/or is a member of the Investigator's staff
- Clinical study participation with any investigational drug less than 30 days prior to study entry or planning to receive an investigational drug during the study period
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the efficacy, safety, tolerability and the concentration/response relationship of E6201 in subjects with psoriasis vulgaris.
Read the detailed description
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.
- Conditions
- Psoriasis Vulgaris
- Being tested
- 0.03% E6201, 0.1% E6201, 0.2% E6201, 0.005% E6201, 0.01% E6201
- Keywords
- Psoriasis vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.03% E6201Drug
Topical 0.03% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
0.1% E6201Drug
Topical 0.1% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
0.2% E6201Drug
Topical 0.2% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
0.005% E6201Drug
Topical 0.005% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
0.01% E6201Drug
Topical 0.01% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
0.05% E6201Drug
Topical 0.05% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
Placebo - 0.03% gel vehicleOther
Topical 0.03% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
Placebo - 0.1% gel vehicleOther
Topical 0.1% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
Placebo - 0.2% gel vehicleOther
Topical 0.2% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
Placebo - 0.05% gel vehicleOther
Topical 0.005% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
Placebo - 0.01% gel vehicleOther
Topical 0.01% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
Placebo - 0.05% gel vehicleOther
Topical 0.05% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
CalcipotrieneDrug
Also called Daivonex
Topical 0.005% calcipotriene (positive control) was applied once daily to individual specific regions of the psoriatic plaque.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 0.03% E6201; Drug: 0.1% E6201; Drug: 0.2% E6201; Other: Placebo - 0.03% gel vehicle; Other: Placebo - 0.1% gel vehicle; Other: Placebo - 0.2% gel vehicle; Drug: Calcipotriene |
| 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. Receives: Drug: 0.005% E6201; Drug: 0.01% E6201; Drug: 0.05% E6201; Other: Placebo - 0.05% gel vehicle; Other: Placebo - 0.01% gel vehicle; Drug: Calcipotriene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 (Baseline), Day 8 (Visit 10), and Day 12 (End of Treatment)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study start15 Mar 2010
- Primary completion11 Dec 2010
- Study completion11 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Mercer, Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268527
- Sponsor's protocol ID
- E6201-E044-204
- Other IDs
- 2009-014815-11, 2009
- Status last verified
- May 2021
- First submitted
- 15 Nov 2010
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01268527
- Acronym / sponsor ID
- E6201-E044-204
- Conditions
- Psoriasis Vulgaris
- Keywords
- Psoriasis vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2010 (actual)
- Primary completion
- 11 Dec 2010 (actual)
- Study completion
- 11 Dec 2010 (actual)
- First posted
- 31 Dec 2010 (estimated)
- Results
- Posted 11 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy, safety, tolerability and the concentration/response relationship of E6201 in subjects with psoriasis vulgaris.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: 0.03% E6201, Drug: 0.1% E6201, Drug: 0.2% E6201, Other: Placebo - 0.03% gel vehicle, Other: Placebo - 0.1% gel vehicle, Other: Placebo - 0.2% gel vehicle, Drug: CalcipotrieneThree 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 | Drug: 0.005% E6201, Drug: 0.01% E6201, Drug: 0.05% E6201, Other: Placebo - 0.05% gel vehicle, Other: Placebo - 0.01% gel vehicle, Drug: CalcipotrieneThree 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic stable plaque psoriasis with one or two stable psoriatic plaques(s) suitable in size and location for five separate treatment fields to be assessed within it.
- Males and females aged between 18 and 75 years of age
- The general physical examination should be normal (excluding the skin examination for psoriasis) unless the Investigator considers an abnormality not to be clinically significant with regard to the study
- Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin at Visit 1 (Screening) and a negative urine pregnancy test prior to starting study drug(s) (Visit 2). Female subjects of childbearing potential must agree to be abstinent or to use a highly effective method of contraception throughout the study period and for 30 days after the last dose of study drug.
- Provide written informed consent
Key exclusion criteria (9 listed)
- Any clinically significant skin diseases other then chronic stable plaque psoriasis
- Other types of psoriasis than chronic stable plaque variant eg, guttate, pustular, erythodermic, etc
- An unstable course of the disease defined as flare(s) in the previous month
- Subjects who used any concommitant topical treatment for the psoriatic plaque(s) to be studied (other than emollients or salicylic acid) within 8 weeks before the Baseline visit eg corticosteroids or topical immunomodulators, anthralin (dithranil), vitamin D derivatives, ultraviolet-light therapy including sunbathing , or retinoids.
- Subjects who used any of the following systemic treatments within 12 weeks before the Baseline visit eg: corticosteroids or adrenocorticotrophic hormone analogs, retinoids such as acitretin or isotretinoin, cyclosporin, interferon, methotrexate, other immuno-suppressive/immunomodulating drugs, psoralen and ultraviolet A therapy, or biologics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.03% E6201Topical 0.03% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. | Drug | Cohort 1 |
| 0.1% E6201Topical 0.1% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. | Drug | Cohort 1 |
| 0.2% E6201Topical 0.2% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. | Drug | Cohort 1 |
| 0.005% E6201Topical 0.005% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. | Drug | Cohort 2 |
| 0.01% E6201Topical 0.01% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. | Drug | Cohort 2 |
| 0.05% E6201Topical 0.05% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque. | Drug | Cohort 2 |
| Placebo - 0.03% gel vehicleTopical 0.03% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. | Other | Cohort 1 |
| Placebo - 0.1% gel vehicleTopical 0.1% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. | Other | Cohort 1 |
| Placebo - 0.2% gel vehicleTopical 0.2% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. | Other | Cohort 1 |
| Placebo - 0.05% gel vehicleTopical 0.005% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. | Other | Cohort 2 |
| Placebo - 0.01% gel vehicleTopical 0.01% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. | Other | Cohort 2 |
| Placebo - 0.05% gel vehicleTopical 0.05% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque. | Other | Cohort 2 |
| CalcipotrieneAlso: DaivonexTopical 0.005% calcipotriene (positive control) was applied once daily to individual specific regions of the psoriatic plaque. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate
Time frame: 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.
5 secondary outcomes
Change in Thickness of the Psoriatic Infiltrate From Baseline to End of Treatment (Day 12/Discontinuation)
Time frame: Day 12/Discontinuation (Visit 14/End of Treatment)
Change in Thickness of the Psoriatic Infiltrate From Baseline to Day 8
Time frame: Day 8 (Visit 10)
Clinical (Global) Assessment of Efficacy at Day 12/Discontinuation
Time frame: Day 12/Discontinuation (Visit 14/End of Treatment)
Clinical (Global) Assessment of Efficacy on Day 8
Time frame: Day 8 (Visit 10)
Overview of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Mercer study director
Eisai Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.03% E6201, 0.1% E6201 and 0.2% E6201 in people with Psoriasis Vulgaris, run by Eisai Limited at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summary Statistics and Primary Pairwise Comparison (Vehicle-E6201) of Area Under the Curve (AUC) for the Baseline-Corrected Thickness of the Psoriatic Infiltrate (time frame: Day 0 (Baseline), Day 8 (Visit 10), and Day 12 (End of Treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.