Plaque PsoriasisPhase 2197-002NCT00796211
A Single-Center Exploratory Study to Assess the Activity of CRx-197-002 in Plaque Psoriasis
A Phase 2 study testing CRx-197, Nortriptyline and Calcipotriol in people with Plaque Psoriasis, run by Zalicus at 1 site in Germany.
Trial summary
This will be a phase 2a single-center, randomized, blinded, vehicle-controlled exploratory study to assess the activity and safety of CRx-197 in subjects with plaque psoriasis. Approximately 20 male or female subjects with chronic plaque type psoriasis, 18 to 70 years of age, will be included in this study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- CRx-197, Nortriptyline and Calcipotriol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to Jan 2009
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- I01 Subject must voluntarily sign and date the written informed consent prior to any study specific procedures
- I02 Subject must be 18 to 70 years of age
- I03 Subject must have chronic plaque psoriasis and plaque infiltrates of a thickness of a minimum of 150 µm and stable plaques in an area sufficient for up to five test fields and an untreated control field per each plaque
- I04 Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
- I05 Females of childbearing potential age should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen.
Who cannot join
- E01 Erythrodermic, guttate or pustular psoriasis
- E02 Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias or valvular heart disease
- E03 Mania or acute delirium or epilepsy
- E04 Narrow angle glaucoma
- E05 Hyperthyroidism by medical history, TSH less than LLN, or a subject receiving thyroid medication
- E06 Diabetes
Show all 21Show fewer
- E07 Intolerance to lidocaine
- E08 Severe liver disease [ALT laboratory value that exceeds 2.5x ULN]
- E09 Known severe kidney disease, acute urinary retention, prostatic hypertrophy with post void residual urine or laboratory value of creatinine that exceeds 1.5x ULN
- E10 Significant gastrointestinal disease including but not limited to pyloric stenosis or paralytic ileus
- E11 Inflammatory dermatoses except psoriasis; bacterial, viral, or fungal skin infections (at the test plaques); facial rosacea
- E12 Active varicella, tuberculosis, syphilis or post-vaccine reactions
- E13 Autoimmune disease other than plaque psoriasis (e.g., lupus erythematosis)
- E14 Known allergic reactions or hypersensitivity to any of the components of the study treatments
- E15 Allergy to adhesives on the templates used in this study
- E16 UV therapy or significant UV exposure in the four weeks before treatment application
- E17 History of malignancy (except for treated or excised basal cell carcinoma)
- E18 History of drug or alcohol abuse (as defined by the Investigator)
- E19 Symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study
- E20 Subject with demonstrated hypercalcemia (calcium greater than ULN) or evidence of Vitamin D toxicity
- E21 Subject with demonstrated hypokalemia (less than LLN)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Blinded, Vehicle- Controlled Exploratory Study to Assess the Activity of CRx-197 in Subjects With Plaque Psoriasis
This will be a phase 2a single-center, randomized, blinded, vehicle-controlled exploratory study to assess the activity and safety of CRx-197 in subjects with plaque psoriasis. Approximately 20 male or female subjects with chronic plaque type psoriasis, 18 to 70 years of age, will be included in this study.
All subjects with stable psoriatic plaques will receive all of the following treatments each in a separate test field, once each day for four weeks under occlusion:
- CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine)
- CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine)
- 0.1% nortriptyline HCl topical cream
- 0.005% calcipotriol topical cream
- Vehicle of CRx-197 topical cream (placebo)
- Conditions
- Plaque Psoriasis
- Being tested
- CRx-197, Nortriptyline, Calcipotriol, Placebo
- Keywords
- Psoriasis, CRx-197, nortriptyline, loratadine, CombinatoRx, Dermatology, Erythema, Pruritus
- Medical subject headings
- Psoriasis, Erythema, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRx-197Drug
CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine)
CRx-197Drug
CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine)
NortriptylineDrug
0.1% nortriptyline HCl topical cream
CalcipotriolDrug
0.005% calcipotriol topical cream
PlaceboOther
Vehicle of CRx-197 topical cream (placebo)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine) Receives: Drug: CRx-197 |
| 2 | Experimental | CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine) Receives: Drug: CRx-197 |
| 3 | Active comparator | 0.1% nortriptyline HCl topical cream Receives: Drug: Nortriptyline |
| 4 | Active comparator | 0.005% calcipotriol topical cream Receives: Drug: Calcipotriol |
| 5 | Placebo comparator | Vehicle of CRx-197 topical cream (placebo) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as assessed by treatment emergent adverse events, physical exams, vital signs, concomitant medications/procedures and subject assessment of pruritus
Measured: 6 weeks
Secondary outcomes (3)
Difference in change from baseline in psoriatic infiltrate measured by ultrasound at Days 8, 15, 22, 29 and 43 between CRx-197, nortriptyline, active comparator as well as vehicle of CRx-197 and untreated test field(s)
Measured: 6 weeks
Differences in change from baseline in erythema measured by chromametry at Days 8, 15, 22, 29 and 43 between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s) and normal skin
Measured: 6 weeks
Modified PASI at Baseline, and Days 8, 15, 22, 29 and 43 between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zalicus
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796211
- Sponsor's protocol ID
- CRx-197-002
- Acronym
- 197-002
- Status last verified
- Jan 2009
- First submitted
- 21 Nov 2008
- Last updated
- 15 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Blinded, Vehicle- Controlled Exploratory Study to Assess the Activity of CRx-197 in Subjects With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00796211
- Acronym / sponsor ID
- 197-002 / CRx-197-002
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis, CRx-197, nortriptyline, loratadine, CombinatoRx, Dermatology, Erythema, Pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ZalicusIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 24 Nov 2008 (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 will be a phase 2a single-center, randomized, blinded, vehicle-controlled exploratory study to assess the activity and safety of CRx-197 in subjects with plaque psoriasis. Approximately 20 male or female subjects with chronic plaque type psoriasis, 18 to 70 years of age, will be included in this study.
All subjects with stable psoriatic plaques will receive all of the following treatments each in a separate test field, once each day for four weeks under occlusion:
- CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine)
- CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine)
- 0.1% nortriptyline HCl topical cream
- 0.005% calcipotriol topical cream
- Vehicle of CRx-197 topical cream (placebo)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CRx-197CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine) |
| 2 | Experimental | Drug: CRx-197CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine) |
| 3 | Active comparator | Drug: Nortriptyline0.1% nortriptyline HCl topical cream |
| 4 | Active comparator | Drug: Calcipotriol0.005% calcipotriol topical cream |
| 5 | Placebo comparator | Other: PlaceboVehicle of CRx-197 topical cream (placebo) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- I01 Subject must voluntarily sign and date the written informed consent prior to any study specific procedures
- I02 Subject must be 18 to 70 years of age
- I03 Subject must have chronic plaque psoriasis and plaque infiltrates of a thickness of a minimum of 150 µm and stable plaques in an area sufficient for up to five test fields and an untreated control field per each plaque
- I04 Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
- I05 Females of childbearing potential age should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen.
Key exclusion criteria (21 listed)
- E01 Erythrodermic, guttate or pustular psoriasis
- E02 Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias or valvular heart disease
- E03 Mania or acute delirium or epilepsy
- E04 Narrow angle glaucoma
- E05 Hyperthyroidism by medical history, TSH less than LLN, or a subject receiving thyroid medication
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 |
|---|---|---|
| CRx-197CRx-197 high dose topical cream (0.1% nortriptyline HCl +0.3% loratadine) | Drug | 1 |
| CRx-197CRx-197 low dose topical cream (0.1% nortriptyline HCl + 0.1% loratadine) | Drug | 2 |
| Nortriptyline0.1% nortriptyline HCl topical cream | Drug | 3 |
| Calcipotriol0.005% calcipotriol topical cream | Drug | 4 |
| PlaceboVehicle of CRx-197 topical cream (placebo) | Other | 5 |
Primary outcome
Safety and tolerability as assessed by treatment emergent adverse events, physical exams, vital signs, concomitant medications/procedures and subject assessment of pruritus
Time frame: 6 weeks
3 secondary outcomes
Difference in change from baseline in psoriatic infiltrate measured by ultrasound at Days 8, 15, 22, 29 and 43 between CRx-197, nortriptyline, active comparator as well as vehicle of CRx-197 and untreated test field(s)
Time frame: 6 weeks
Differences in change from baseline in erythema measured by chromametry at Days 8, 15, 22, 29 and 43 between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s) and normal skin
Time frame: 6 weeks
Modified PASI at Baseline, and Days 8, 15, 22, 29 and 43 between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s)
Time frame: 6 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 15 Jan 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 CRx-197, Nortriptyline and Calcipotriol in people with Plaque Psoriasis, run by Zalicus 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 5 inclusion and 21 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 15 Jan 2009. 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. Some participants in this study may receive a placebo. 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?
Safety and tolerability as assessed by treatment emergent adverse events, physical exams, vital signs, concomitant medications/procedures and subject assessment of pruritus (time frame: 6 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 15 Jan 2009; AzTrials last refreshed its copy on 31 Oct 2026.