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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT # 2008-000611-15 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRx-197 high dose (0.1% nortriptyline HCl + 0.3% loratadine) | Experimental |
| |
| CRx-197 low dose (0.1% nortriptyline HCl + 0.1% loratadine) | Experimental |
| |
| 0.1% nortriptyline HCl | Experimental |
| |
| 0.1% mometasone furoate | Active Comparator |
| |
| Active ingredient free vehicle cream of CRx-197 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nortriptyline HCl + loratadine | Drug | Topical |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jutta Harten, MD | Proinnovera GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PROINNOVERA GmbH | Münster | Germany |
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| nortriptyline HCl + loratadine | Drug | Topical |
|
| nortriptyline HCl | Drug | Topical |
|
| mometasone furoate | Drug | Topical |
|
| Active ingredient free vehicle cream of CRx-197 | Drug | Topical |
|
| Days 8, 15, 22, 29 and 43 |
| Modified PASI between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s) | Baseline, and Days 8, 15, 22, 29 and 43 |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D009661 | Nortriptyline |
| D017336 | Loratadine |
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D003533 | Cyproheptadine |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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