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| Descriptive Information Fields | |||||
| Brief Title † | Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis | ||||
| Official Title † | Double-Blind, Bilateral, Vehicle-Controlled, Randomized Trial of Neuroskin Forte to Relieve Symptoms of Dry Skin | ||||
| Brief Summary | The purpose of this study is to assess the efficacy of Neuroskin Forte in relieving the symptoms of dry skin in adults with psoriasis or eczema. |
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| Detailed Description | Subjects will apply study drug and placebo sprays 3 times a day to the assigned, randomized sides of the body. They are allowed to continue using prescription medications, but not moisturizers. Assessments will be performed every other week. Total duration of the study is 10 weeks (8 weeks of treatment and a follow-up visit 2 weeks later). |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment | ||||
| Primary Outcome Measure † | Percent improvement from baseline in the Visual Analog Scale (VAS) score for pruritus (itching) at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Psoriasis ½-body physician global assessment (PGA) improvement of at least 2 levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] Eczema ½-body investigator global assessment (IGA) improvement of at least 2 levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] Improvement in target lesion scoring [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] Photography of target lesions [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] |
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| Condition † | Psoriasis Eczema |
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| Intervention † | Drug: Neuroskin Forte Drug: Placebo Application |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 40 | ||||
| Start Date † | September 2005 | ||||
| Completion Date | December 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria
Exclusion Criteria
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00143819 | ||||
| Organization ID | 5494 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | University of Medicine and Dentistry New Jersey | ||||
| Collaborators †† | AVVAA World Healthcare Products, Inc. | ||||
| Investigators † |
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| Information Provided By | University of Medicine and Dentistry New Jersey | ||||
| Verification Date | February 2008 | ||||
| First Received Date † | August 31, 2005 | ||||
| Last Updated Date | September 12, 2008 | ||||