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

Sponsor:	University of Medicine and Dentistry New Jersey
Collaborator:	AVVAA World Healthcare Products, Inc.
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00143819

Purpose

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.

Condition	Intervention	Phase
Psoriasis Eczema	Drug: Neuroskin Forte Drug: Placebo Application	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Double-Blind, Bilateral, Vehicle-Controlled, Randomized Trial of Neuroskin Forte to Relieve Symptoms of Dry Skin

Resource links provided by NLM:

MedlinePlus related topics: Eczema Psoriasis

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

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 Measures:

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 ]

Estimated Enrollment:	40
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2007
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator bilateral comparison	Drug: Neuroskin Forte Subjects will apply study drug sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks
2: Placebo Comparator bilateral comparison	Drug: Placebo Application Subjects will apply placebo sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143819

Contacts

Contact: Irina Lipets, RN, BSN

732-235-5737

lipetsir@umdnj.edu

Locations

United States, New Jersey
UMDNJ Division of Clinical Pharmacology	Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Patricia Hanas 732-235-8063 hanaspw@umdnj.edu

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

AVVAA World Healthcare Products, Inc.

Investigators

Principal Investigator:

Melissa Magliocco, MD

University of Medicine and Dentistry New Jersey

More Information

No publications provided

Responsible Party:	UMDNJ-RWJMS ( Melissa Magliocco, MD )
Study ID Numbers:	5494
Study First Received:	August 31, 2005
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00143819 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

psoriasis
dry skin
eczema
atopic dermatitis

Additional relevant MeSH terms:

Skin Diseases
Psoriasis
Skin Diseases, Eczematous

Eczema
Skin Diseases, Papulosquamous
Dermatitis

ClinicalTrials.gov processed this record on November 27, 2009