Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis

This study has been completed.

Sponsor:

Collaborator:

AVVAA World Healthcare Products, Inc.

Information provided by (Responsible Party):

Clinical Pharmacology, University of Medicine and Dentistry New Jersey

ClinicalTrials.gov Identifier:

NCT00143819

First received: August 31, 2005

Last updated: June 28, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 31, 2005

Last Updated Date

June 28, 2012

Start Date ^ICMJE

September 2005

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

· Percent improvement from baseline in the Visual Analog Scale (VAS) score for pruritus (itching) at 8 weeks

Change History

Complete list of historical versions of study NCT00143819 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

· 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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis

Official Title ^ICMJE

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Psoriasis
Eczema

Intervention ^ICMJE

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
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

Study Arm (s)

Active Comparator: 1
bilateral comparison

Intervention: Drug: Neuroskin Forte
Placebo Comparator: 2
bilateral comparison

Intervention: Drug: Placebo Application

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2010

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00143819

Other Study ID Numbers ^ICMJE

5494

Has Data Monitoring Committee

Responsible Party

Clinical Pharmacology, University of Medicine and Dentistry New Jersey

Study Sponsor ^ICMJE

University of Medicine and Dentistry New Jersey

Collaborators ^ICMJE

AVVAA World Healthcare Products, Inc.

Investigators ^ICMJE

Principal Investigator:

Melissa Magliocco, MD

University of Medicine and Dentistry New Jersey

Information Provided By

University of Medicine and Dentistry New Jersey

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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