Chronic Plaque PsoriasisPhase 2NCT00539929
Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis
A Phase 2 study testing E6201 0.005%, E6201 0.01% and E6201 0.03% in people with Chronic Plaque Psoriasis, run by Eisai Inc. at 12 sites in United States.
Trial summary
This is a double-blind, multicenter study to assess the efficacy and safety of E6201 topical administration to pre-identified marker lesions in adult subjects with chronic plaque type psoriasis. Treatment duration is 8 weeks, followed by a 4-week period without treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- E6201 0.005%, E6201 0.01% and E6201 0.03%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 12 sitesUnited States
- Study dates
- Sep 2007to Jul 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 18 years or older with a clinical diagnosis of mild-to-moderate plaque-type psoriasis for ≥12 months prior to screening
- Female participants postmenopausal >1 year or surgically sterile
- Two representative and similar target lesions for the condition, each of 15-25 centimeters squared (cm^2), up to 50 cm^2 in surface area
- Target lesion severity score of 4-8 on a scale of 0 to 12, where, in the opinion of the Investigator, 0 equals no evidence of disease and 12 equals severe induration, erythema, scaling, and pruritus
- Prescription medications, if applicable, for chronic conditions allowed but must be on a stable regimen prior to and during the study; this is also applicable for dietary supplements and over-the-counter (OTC) drugs
- Participants able and willing to give informed consent
Who cannot join
- Use of any, concomitant, topical treatment for psoriasis, excluding emollients
- Use of any, concomitant, systemic treatment for psoriasis, including ultraviolet radiation (UVR) light
- Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, psychiatric, musculoskeletal, rheumatologic, or cardiovascular system abnormalities
- Evidence of any clinically significant deviation from normal with respect to medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory determinations. If any participant has an abnormal clinical laboratory test finding that meets specified criteria, that participant will be re-tested by repeated blood draw and clinical laboratory assessment. If the abnormal test finding is confirmed, the participant will be excluded from the study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Study site
Austin, Texas
Study site
Boise, Idaho
Study site
Carlstadt, New Jersey
Study site
Champaign, Illinois
Study site
Clinton Township, Michigan
Study site
College Station, Texas
Study site
Fridley, Minnesota
Study site
Hot Springs, Arkansas
Study site
Lynchburg, Virginia
Study site
Omaha, Nebraska
Study site
Portland, Oregon
Study site
San Diego, California
About this study
Official title: Proof of Principle, Randomized, Parallel-Group, Double-Blind, Vehicle-Controlled, Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis
This is a double-blind, multicenter study to assess the efficacy and safety of E6201 topical administration to pre-identified marker lesions in adult subjects with chronic plaque type psoriasis. Treatment duration is 8 weeks, followed by a 4-week period without treatment. Pharmacokinetic samples will be obtained pre-and post treatment.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- E6201 0.005%, E6201 0.01%, E6201 0.03%, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6201 0.005%Drug
E6201 0.01%Drug
E6201 0.03%Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| E6201 0.005% BID | Experimental | Participants applied E6201 0.005% cream to a pre-identified marker lesion twice a day (BID) for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. Receives: Drug: E6201 0.005%; Drug: Placebo |
| E6201 0.01% BID | Experimental | Participants applied E6201 0.01% cream to a pre-identified marker lesion BID for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. Receives: Drug: E6201 0.01%; Drug: Placebo |
| E6201 0.03% BID | Experimental | Participants applied E6201 0.03% cream to a pre-identified marker lesion BID for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. Receives: Drug: E6201 0.03%; Drug: Placebo |
| E6201 0.03% QD | Experimental | Participants applied E6201 0.03% cream to a pre-identified marker lesion once a day (QD) for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. Receives: Drug: E6201 0.03%; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Symptom Severity (TSS) at week 8.
Measured: 8 weeks
Secondary outcomes (1)
Total Symptom Severity (TSS) at all other time points; Physician's Global Assessment (PGA); safety; pharmacokinetics (PK)
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eisai US Medical Services, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539929
- Sponsor's protocol ID
- E6201-A001-201
- Status last verified
- Jan 2017
- First submitted
- 3 Oct 2007
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Principle, Randomized, Parallel-Group, Double-Blind, Vehicle-Controlled, Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis
- ClinicalTrials.gov ID
- NCT00539929
- Acronym / sponsor ID
- E6201-A001-201
- Conditions
- Chronic Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 5 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, multicenter study to assess the efficacy and safety of E6201 topical administration to pre-identified marker lesions in adult subjects with chronic plaque type psoriasis. Treatment duration is 8 weeks, followed by a 4-week period without treatment. Pharmacokinetic samples will be obtained pre-and post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| E6201 0.005% BID | Experimental | Drug: E6201 0.005%, Drug: PlaceboParticipants applied E6201 0.005% cream to a pre-identified marker lesion twice a day (BID) for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. |
| E6201 0.01% BID | Experimental | Drug: E6201 0.01%, Drug: PlaceboParticipants applied E6201 0.01% cream to a pre-identified marker lesion BID for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. |
| E6201 0.03% BID | Experimental | Drug: E6201 0.03%, Drug: PlaceboParticipants applied E6201 0.03% cream to a pre-identified marker lesion BID for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. |
| E6201 0.03% QD | Experimental | Drug: E6201 0.03%, Drug: PlaceboParticipants applied E6201 0.03% cream to a pre-identified marker lesion once a day (QD) for 8 weeks. Participants applied matching placebo cream to another pre-identified marker lesion at the same treatment regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females 18 years or older with a clinical diagnosis of mild-to-moderate plaque-type psoriasis for ≥12 months prior to screening
- Female participants postmenopausal >1 year or surgically sterile
- Two representative and similar target lesions for the condition, each of 15-25 centimeters squared (cm^2), up to 50 cm^2 in surface area
- Target lesion severity score of 4-8 on a scale of 0 to 12, where, in the opinion of the Investigator, 0 equals no evidence of disease and 12 equals severe induration, erythema, scaling, and pruritus
- Prescription medications, if applicable, for chronic conditions allowed but must be on a stable regimen prior to and during the study; this is also applicable for dietary supplements and over-the-counter (OTC) drugs
Key exclusion criteria (4 listed)
- Use of any, concomitant, topical treatment for psoriasis, excluding emollients
- Use of any, concomitant, systemic treatment for psoriasis, including ultraviolet radiation (UVR) light
- Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, psychiatric, musculoskeletal, rheumatologic, or cardiovascular system abnormalities
- Evidence of any clinically significant deviation from normal with respect to medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory determinations. If any participant has an abnormal clinical laboratory test finding that meets specified criteria, that participant will be re-tested by repeated blood draw and clinical laboratory assessment. If the abnormal test finding is confirmed, the participant will be excluded from the study.
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 |
|---|---|---|
| E6201 0.005% | Drug | E6201 0.005% BID |
| E6201 0.01% | Drug | E6201 0.01% BID |
| E6201 0.03% | Drug | E6201 0.03% BID, E6201 0.03% QD |
| Placebo | Drug | E6201 0.005% BID, E6201 0.01% BID, E6201 0.03% BID, E6201 0.03% QD |
Primary outcome
Total Symptom Severity (TSS) at week 8.
Time frame: 8 weeks
1 secondary outcome
Total Symptom Severity (TSS) at all other time points; Physician's Global Assessment (PGA); safety; pharmacokinetics (PK)
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
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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.
Eisai US Medical Services study director
Eisai Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E6201 0.005%, E6201 0.01% and E6201 0.03% in people with Chronic Plaque Psoriasis, run by Eisai Inc. at 12 sites in United States.
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 4 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 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Symptom Severity (TSS) at week 8. (time frame: 8 weeks). 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 6 Feb 2017.