| August 31, 2005 |
| October 22, 2008 |
| September 2005 |
| June 2009 (final data collection date for 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 ] |
| · Percent improvement from baseline in the Visual Analog Scale (VAS) score for pruritus (itching) at 8 weeks |
| Complete list of historical versions of study NCT00143819 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- · Psoriasis ½-body PGA improvement of at least 2 levels at 8 weeks
- · Eczema ½-body IGA improvement of at least 2 levels at 8 weeks
- · Improvement in target lesion scoring
- · Photography of target lesions
|
| |
| Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis |
| Double-Blind, Bilateral, Vehicle-Controlled, Randomized Trial of Neuroskin Forte to Relieve Symptoms of Dry Skin |
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. |
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). |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
|
|
- Drug: Neuroskin Forte
- Drug: Placebo Application
|
- Active Comparator: bilateral comparison
- Placebo Comparator: bilateral comparison
|
| |
| |
| Recruiting |
| 40 |
| December 2007 |
| June 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria
- Must be at least 18 years of age
- Have psoriasis or eczema on both sides of the body, with a pair of roughly symmetrical bilateral "target" lesions at least 1.5 cm in diameter
Exclusion Criteria
- Inability to understand the consent form and/or comply with the requirements of this study
- Use of moisturizers/emollients within 2 days of beginning study
|
| Both |
| 18 Years and older |
| No |
|
|
| United States |
| |
| NCT00143819 |
| Melissa Magliocco, MD, UMDNJ-RWJMS |
| 5494 |
| University of Medicine and Dentistry New Jersey |
| AVVAA World Healthcare Products, Inc. |
| Principal Investigator: |
Melissa Magliocco, MD |
University of Medicine and Dentistry New Jersey |
|
|
| University of Medicine and Dentistry New Jersey |
| October 2008 |
