Atopic DermatitisPhase 1NCT00721331
A Phase I Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers
A Phase 1 study testing nortriptyline HCl + loratadine, nortriptyline HCl and mometasone furoate in people with Atopic Dermatitis, run by Zalicus at 1 site in Germany.
Trial summary
This will be a phase I, single center, randomized, vehicle-controlled, blinded study comparing two dosage strengths of CRx-197 cream, nortriptyline, an active comparator (0.1% mometasone) and placebo (the active ingredient free vehicle cream of CRx-197)in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- nortriptyline HCl + loratadine, nortriptyline HCl and mometasone furoate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to Sep 2008
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures
- Subject must be 18 to 60 years of age
- Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test fields
- Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
- Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen. A highly effective method of birth control is defined as those which result in a lower failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner.
Who cannot join
- Suntan, hyper- or hypo-pigmentation, or tattoos in the area where they will place 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 less than LLN, or subject receiving any thyroid medication
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- Severe liver disease - ALT laboratory value that exceeds 1.5x ULN
- Inflammatory dermatoses (e.g., atopic dermatoses/eczema, psoriasis)
- Any skin condition involving the test fields including but not limited to bacterial, viral, or fungal skin infections, acne, 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 treatments
- Allergy to adhesives on the patches used for occlusion in the study
- UV therapy or significant UV exposure in the four weeks before treatment application
- 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 treatment application that may influence the outcome of the study
- Positive for HIV antibody
- Systemic treatments in the four weeks prior to treatment application that may interact with any of the study drugs, such as: Glucocorticoids, MAO inhibitors, anti-depressants, anti-seizure medications, anti-psychotics and anti-histamines
- Subjects who require medications that inhibit the CYP450 2D6 pathway such as:Quinidine, Cimetidine, Type 1 anti-arrhythmic, Phenothiazines, Selective serotonin reuptake inhibitors, Reserpine, other anticholinergic drugs, and sympathomimetic drugs
- Treatment with any investigational agent within one month before treatment application for this trial
- Female subject who is pregnant , lactating, or with a positive pregnancy test
- 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, 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-Controlled Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers
This will be a phase I, single center, randomized, vehicle-controlled, blinded study comparing two dosage strengths of CRx-197 cream, nortriptyline, an active comparator (0.1% mometasone) and placebo (the active ingredient free vehicle cream of CRx-197)in healthy volunteers.
- Conditions
- Atopic Dermatitis
- Being tested
- nortriptyline HCl + loratadine, nortriptyline HCl, mometasone furoate, Active ingredient free vehicle cream of CRx-197
- Keywords
- CombinatoRx, Atopic, Dermatitis, Topical, CRx-197, Normal Healthy Volunteers
- Medical subject headings
- Dermatitis, Atopic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nortriptyline HCl + loratadineDrug
Topical
nortriptyline HCl + loratadineDrug
Topical
nortriptyline HClDrug
Topical
mometasone furoateDrug
Topical
Active ingredient free vehicle cream of CRx-197Drug
Topical
| Study group | Role | What they receive |
|---|---|---|
| CRx-197 high dose (0.1% nortriptyline HCl + 0.3% loratadine) | Experimental | Not described Receives: Drug: nortriptyline HCl + loratadine |
| CRx-197 low dose (0.1% nortriptyline HCl + 0.1% loratadine) | Experimental | Not described Receives: Drug: nortriptyline HCl + loratadine |
| 0.1% nortriptyline HCl | Experimental | Not described Receives: Drug: nortriptyline HCl |
| 0.1% mometasone furoate | Active comparator | Not described Receives: Drug: mometasone furoate |
| Active ingredient free vehicle cream of CRx-197 | Placebo comparator | Not described Receives: Drug: Active ingredient free vehicle cream of CRx-197 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of CRx-197 as assessed by treatment emergent adverse events, physical exams, vital signs, concomitant medications/procedures and subject assessment of pruritus.
Measured: 2 months
Secondary outcomes (3)
Difference in change from baseline in psoriatic infiltrate measured by ultrasound between CRx-197, nortriptyline, active comparator as well as vehicle of CRx-197 and untreated test field(s)
Measured: Days 8, 15, 22, 29 and 43
Difference in change from baseline in erythema measured by chronometry between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s) and normal skin
Measured: Days 8, 15, 22, 29 and 43
Modified PASI between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s)
Measured: Baseline, and Days 8, 15, 22, 29 and 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Factorial
- 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)
- Investigators
- Jutta Harten, MD, Principal investigator, Proinnovera GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721331
- Sponsor's protocol ID
- CRx-197-001
- Other IDs
- EudraCT # 2008-000611-15
- Status last verified
- Sep 2008
- First submitted
- 21 Jul 2008
- Last updated
- 26 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Randomized, Vehicle-Controlled Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00721331
- Acronym / sponsor ID
- CRx-197-001
- Conditions
- Atopic Dermatitis
- Keywords
- CombinatoRx, Atopic, Dermatitis, Topical, CRx-197, Normal Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ZalicusIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Jul 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 I, single center, randomized, vehicle-controlled, blinded study comparing two dosage strengths of CRx-197 cream, nortriptyline, an active comparator (0.1% mometasone) and placebo (the active ingredient free vehicle cream of CRx-197)in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CRx-197 high dose (0.1% nortriptyline HCl + 0.3% loratadine) | Experimental | Drug: nortriptyline HCl + loratadine |
| CRx-197 low dose (0.1% nortriptyline HCl + 0.1% loratadine) | Experimental | Drug: nortriptyline HCl + loratadine |
| 0.1% nortriptyline HCl | Experimental | Drug: nortriptyline HCl |
| 0.1% mometasone furoate | Active comparator | Drug: mometasone furoate |
| Active ingredient free vehicle cream of CRx-197 | Placebo comparator | Drug: Active ingredient free vehicle cream of CRx-197 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures
- Subject must be 18 to 60 years of age
- Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test fields
- Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
- Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen. A highly effective method of birth control is defined as those which result in a lower failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner.
Key exclusion criteria (26 listed)
- Suntan, hyper- or hypo-pigmentation, or tattoos in the area where they will place 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 |
|---|---|---|
| nortriptyline HCl + loratadineTopical | Drug | CRx-197 high dose (0.1% nortriptyline HCl + 0.3% loratadine) |
| nortriptyline HCl + loratadineTopical | Drug | CRx-197 low dose (0.1% nortriptyline HCl + 0.1% loratadine) |
| nortriptyline HClTopical | Drug | 0.1% nortriptyline HCl |
| mometasone furoateTopical | Drug | 0.1% mometasone furoate |
| Active ingredient free vehicle cream of CRx-197Topical | Drug | Active ingredient free vehicle cream of CRx-197 |
Primary outcome
Safety and tolerability of CRx-197 as assessed by treatment emergent adverse events, physical exams, vital signs, concomitant medications/procedures and subject assessment of pruritus.
Time frame: 2 months
3 secondary outcomes
Difference in change from baseline in psoriatic infiltrate measured by ultrasound between CRx-197, nortriptyline, active comparator as well as vehicle of CRx-197 and untreated test field(s)
Time frame: Days 8, 15, 22, 29 and 43
Difference in change from baseline in erythema measured by chronometry between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s) and normal skin
Time frame: Days 8, 15, 22, 29 and 43
Modified PASI between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s)
Time frame: Baseline, and Days 8, 15, 22, 29 and 43
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 26 Sep 2008.
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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.
Jutta Harten, MD principal investigator
Proinnovera 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 nortriptyline HCl + loratadine, nortriptyline HCl and mometasone furoate in people with Atopic Dermatitis, 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 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 26 Sep 2008. 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?
Safety and tolerability of CRx-197 as assessed by treatment emergent adverse events, physical exams, vital signs, concomitant medications/procedures and subject assessment of pruritus. (time frame: 2 months). 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 26 Sep 2008.