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
  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 2

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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of 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 ]

Enrollment: 13
Study Start Date: September 2005
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
AVVAA World Healthcare Products, Inc.
Investigators
Principal Investigator: Melissa Magliocco, MD Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Clinical Pharmacology, Assistant Professor, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00143819     History of Changes
Other Study ID Numbers: 5494
Study First Received: August 31, 2005
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
psoriasis
dry skin
eczema
atopic dermatitis

Additional relevant MeSH terms:
Eczema
Psoriasis
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 21, 2014