Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis

Psoriasis Clinical Trial

Official title:

Double-Blind, Bilateral, Vehicle-Controlled, Randomized Trial of Neuroskin Forte to Relieve Symptoms of Dry Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143819
• Other study ID #: 5494
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2005
• Last updated: February 2, 2015
• Start date: September 2005
• Est. completion date: February 2010

Study information

• Verified date: February 2015
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Eczema
• Psoriasis

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	AVVAA World Healthcare Products, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent improvement from baseline in the Visual Analog Scale (VAS) score for pruritus (itching) at 8 weeks		8 weeks	No
Secondary	Psoriasis ½-body physician global assessment (PGA) improvement of at least 2 levels		8 weeks	No
Secondary	Eczema ½-body investigator global assessment (IGA) improvement of at least 2 levels		8 weeks	No
Secondary	Improvement in target lesion scoring		8 weeks	No
Secondary	Photography of target lesions		8 weeks	No