HealthyPhase 1NCT00544687
Phase I Study of Topical CRx-191 in Normal Healthy Volunteers
A Phase 1 study testing CRx-191, mometasone furoate and nortriptyline HCl in people with Healthy, run by Zalicus at 1 site in Germany.
Trial summary
CRx-191 is a proprietary synergistic combination drug candidate being evaluated by CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor- alpha and interferon-gamma release, cytokines… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CRx-191, mometasone furoate and nortriptyline HCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Nov 2007
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must voluntarily give written informed consent
- Subject must be at least 18 years of age
- Subject must have healthy skin on which reddening can be easily recognized in the area of the test fields
- The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study
- Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen; systemic contraceptive (combined oral contraceptive, implant, injection), or safe intrauterine device (IUD)
- Written informed consent obtained
Who cannot join
- Acne, suntan, eczema, hyper- or hypopigmentation, or tattoos in the test fields
- Dark skinned persons whose skin color prevents ready assessment of skin reactions
- Cardiac disease including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
- Mania
- Narrow angle glaucoma
- Hyperthyroidism by medical history, TSH < LLN, or receiving thyroid medication
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- Severe liver disease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values that exceed 1.5x ULN)
- Inflammatory dermatoses (e.g. atopic dermatitis, psoriasis), bacterial, viral, or fungal skin infections; facial rosacea
- Active varicella, tuberculosis, syphilis or post-vaccine reactions
- Autoimmune disease (e.g., lupus erythematosis)
- Known allergic reactions or hypersensitivity to any of the components of the study preparations
- Allergy to adhesives on the patches used for occlusion in this study
- UV therapy in the four weeks before the study
- History of malignancy (except for treated or excised basal cell carcinoma)
- Surgery within the previous 3 months (except for minor cosmetic or dental procedures)
- History of drug or alcohol abuse (as defined by the Investigator)
- Symptoms of a clinically significant illness in the four weeks before the study that may influence the outcome of the study
- Positive for human immunodeficiency virus (HIV) antibody
- Systemic treatments in the two weeks preceding and during the study that may interact with any of the study drugs, such as: Glucocorticoids (po, im, iv), MAO inhibitors, Anti-depressants, Anti-seizure medications, Anti-psychotics, Antihistamines
- Subjects who require medications that inhibit the cytochrome P450 (CYP450) 2D6 pathway such as: Quinidine, Cimetidine, Type 1 antiarrhythmics, Phenothiazines, Selective serotonin reuptake inhibitors such as fluoxetine, paroxetine, and sertraline, reserpine, other anticholinergic drugs, and sympathomimetic drugs
- Participation in another clinical trial and/or treatment received with any investigational agent within one month before the initial dose of study medication
- Female subject who is pregnant or lactating
- Significant UV exposure in the four weeks before the study
- Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule
- Other unspecified reasons that, in the opinion of the Investigator or sponsor make the subject unsuitable for enrollment
- Subject is institutionalized because of legal or regulatory order
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Center, Randomized, Vehicle and Active-Controlled Study to Assess and Compare the Atrophy-Causing Potential of Topical CRx-191 Formulations in Healthy Volunteers
CRx-191 is a proprietary synergistic combination drug candidate being evaluated by CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor- alpha and interferon-gamma release, cytokines that are implicated in the pathogenesis of psoriasis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRx-191Drug
topical (mometasone furoate + nortriptyline HCl)
mometasone furoateDrug
topical mometasone furoate
nortriptyline HClDrug
topical nortriptyline HCl
Karison® CremeDrug
topical Karison® Creme (clobetasol-17-propinate 0.05%)
VehicleDrug
topical (placebo)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CRx-191 (0.1% mometasone furoate + 0.05% nortriptyline HCl) Receives: Drug: CRx-191 |
| 2 | Experimental | CRx-191 (0.1% mometasone furoate + 0.1% nortriptyline HCl) Receives: Drug: CRx-191 |
| 3 | Active comparator | 0.1% mometasone furoate Receives: Drug: mometasone furoate |
| 4 | Active comparator | 0.1% nortriptyline HCl Receives: Drug: nortriptyline HCl |
| 5 | Active comparator | Karison® Creme (clobetasol-17-propinate 0.05%) Receives: Drug: Karison® Creme |
| 6 | Placebo comparator | Vehicle (placebo) Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full skin thinning produced by treatment of CRx-191 in comparison with its components at corresponding dose levels, and vehicle with a marketed corticosteriod. Assess tolerability and safety of CRx-191.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startSep 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zalicus
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johannes Gassmueller, M.D., Principal investigator, Bioskin GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544687
- Sponsor's protocol ID
- CRx-191-002
- Other IDs
- EudraCT Number: 2006-005903-33
- Status last verified
- Nov 2007
- First submitted
- 15 Oct 2007
- Last updated
- 15 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Randomized, Vehicle and Active-Controlled Study to Assess and Compare the Atrophy-Causing Potential of Topical CRx-191 Formulations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00544687
- Acronym / sponsor ID
- CRx-191-002
- Conditions
- Healthy
- Keywords
- Skin, Atrophy, CRX-191, mometasone furoate, nortriptyline hydrochloride, Skin Thickness in Normal Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ZalicusIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Study completion
- Nov 2007 (actual)
- First posted
- 16 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.
CRx-191 is a proprietary synergistic combination drug candidate being evaluated by CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor- alpha and interferon-gamma release, cytokines that are implicated in the pathogenesis of psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CRx-191CRx-191 (0.1% mometasone furoate + 0.05% nortriptyline HCl) |
| 2 | Experimental | Drug: CRx-191CRx-191 (0.1% mometasone furoate + 0.1% nortriptyline HCl) |
| 3 | Active comparator | Drug: mometasone furoate0.1% mometasone furoate |
| 4 | Active comparator | Drug: nortriptyline HCl0.1% nortriptyline HCl |
| 5 | Active comparator | Drug: Karison® CremeKarison® Creme (clobetasol-17-propinate 0.05%) |
| 6 | Placebo comparator | Drug: VehicleVehicle (placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must voluntarily give written informed consent
- Subject must be at least 18 years of age
- Subject must have healthy skin on which reddening can be easily recognized in the area of the test fields
- The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study
- Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen; systemic contraceptive (combined oral contraceptive, implant, injection), or safe intrauterine device (IUD)
Key exclusion criteria (26 listed)
- Acne, suntan, eczema, hyper- or hypopigmentation, or tattoos in the test fields
- Dark skinned persons whose skin color prevents ready assessment of skin reactions
- Cardiac disease including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
- Mania
- Narrow angle glaucoma
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-191topical (mometasone furoate + nortriptyline HCl) | Drug | 1, 2 |
| mometasone furoatetopical mometasone furoate | Drug | 3 |
| nortriptyline HCltopical nortriptyline HCl | Drug | 4 |
| Karison® Cremetopical Karison® Creme (clobetasol-17-propinate 0.05%) | Drug | 5 |
| Vehicletopical (placebo) | Drug | 6 |
Primary outcome
Full skin thinning produced by treatment of CRx-191 in comparison with its components at corresponding dose levels, and vehicle with a marketed corticosteriod. Assess tolerability and safety of CRx-191.
Time frame: 28 Days
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 Nov 2007.
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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.
Johannes Gassmueller, M.D. principal investigator
Bioskin GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CRx-191, mometasone furoate and nortriptyline HCl in people with Healthy, 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 6 inclusion and 26 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 Nov 2007. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Full skin thinning produced by treatment of CRx-191 in comparison with its components at corresponding dose levels, and vehicle with a marketed corticosteriod. Assess tolerability and safety of CRx-191. (time frame: 28 Days). 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 Nov 2007.