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Sponsored by: |
CombinatoRx |
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Information provided by: | CombinatoRx |
ClinicalTrials.gov Identifier: | NCT00544687 |
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.
Condition | Intervention | Phase |
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Healthy |
Drug: CRx-191 Drug: mometasone furoate Drug: nortriptyline HCl Drug: Karison® Creme Drug: Vehicle |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety 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 |
Enrollment: | 20 |
Study Start Date: | September 2007 |
Study Completion Date: | November 2007 |
Arms | Assigned Interventions |
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1: Experimental
CRx-191 (0.1% mometasone furoate + 0.05% nortriptyline HCl)
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Drug: CRx-191
topical (mometasone furoate + nortriptyline HCl)
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2: Experimental
CRx-191 (0.1% mometasone furoate + 0.1% nortriptyline HCl)
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Drug: CRx-191
topical (mometasone furoate + nortriptyline HCl)
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3: Active Comparator
0.1% mometasone furoate
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Drug: mometasone furoate
topical mometasone furoate
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4: Active Comparator
0.1% nortriptyline HCl
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Drug: nortriptyline HCl
topical nortriptyline HCl
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5: Active Comparator
Karison® Creme (clobetasol-17-propinate 0.05%)
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Drug: Karison® Creme
topical Karison® Creme (clobetasol-17-propinate 0.05%)
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6: Placebo Comparator
Vehicle (placebo)
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Drug: Vehicle
topical (placebo)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CRx-191-002, EudraCT Number: 2006-005903-33 |
Study First Received: | October 15, 2007 |
Last Updated: | November 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00544687 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Skin Atrophy CRX-191 |
mometasone furoate nortriptyline hydrochloride Skin Thickness in Normal Healthy Volunteers |
Anti-Inflammatory Agents Clobetasol Neurotransmitter Agents Adrenergic Agents Mometasone furoate Nortriptyline |
Psychotropic Drugs Atrophy Anti-Allergic Agents Healthy Antidepressive Agents Antidepressive Agents, Tricyclic |
Anti-Inflammatory Agents Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Mometasone furoate Physiological Effects of Drugs |
Psychotropic Drugs Anti-Allergic Agents Pharmacologic Actions Antidepressive Agents, Tricyclic Therapeutic Uses Nortriptyline Central Nervous System Agents Antidepressive Agents |