Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis - Tabular View

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Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis

This study is currently recruiting participants.

Study NCT00143819. Last updated on September 12, 2008. Information provided by University of Medicine and Dentistry New Jersey

This Tabular View shows the required WHO registration data elements as marked by ^†

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.

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).

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 ]

Condition ^†

Psoriasis
Eczema

Intervention ^†

Drug: Neuroskin Forte
Drug: Placebo Application

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

September 2005

Completion Date

December 2007

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Irina Lipets, RN, BSN

732-235-5737

lipetsir@umdnj.edu

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 ^†

Principal Investigator:

Melissa Magliocco, MD

University of Medicine and Dentistry New Jersey

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

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.