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Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis

This study has been terminated.
(Low enrollment)
Sponsor:
Collaborator:
AVVAA World Healthcare Products, Inc.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00143819
First received: August 31, 2005
Last updated: April 7, 2017
Last verified: April 2017

August 31, 2005
April 7, 2017
September 2005
February 2010   (Final data collection date for primary outcome measure)
Change From Baseline in the Visual Analog Scale (VAS) Score for Pruritus (Itching) at 8 Weeks [ Time Frame: 8 weeks ]
Subjects assessed the level of pruritus (itching) on the left and right sides of their body at each visit, ticking the values on a 100-mm scale (0 mm = no itching; 100 mm = worst possible itching) for each side. Percent change from baseline was calculated.
· Percent improvement from baseline in the Visual Analog Scale (VAS) score for pruritus (itching) at 8 weeks
Complete list of historical versions of study NCT00143819 on ClinicalTrials.gov Archive Site
  • Number of Participants With a Psoriasis ½-Body Physician Global Assessment (PGA) Improvement of at Least 2 Levels [ Time Frame: 8 weeks ]
    For subjects with psoriasis, a global assessment (scale of 0-5: 0 = clear except for residual discoloration; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 = severe) was performed and a score recorded for each side of the subject's body, at each visit.
  • Number of Participants With an Eczema ½-Body Investigator Global Assessment (IGA) Improvement of at Least 2 Levels [ Time Frame: 8 weeks ]
    For subjects with eczema, a global assessment (scale of 0-5: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe; 5 = very severe) was performed and a score recorded for each side of the subject's body, at each visit.
  • Change in Target Lesion Scoring [ Time Frame: 8 weeks ]
    The subjects' target lesions (ie, a pair of roughly symmetrical bilateral lesions) on each side of the body were scored by the investigator at each visit. Percent change from baseline was calculated.
  • Photography of Target Lesions [ Time Frame: 8 weeks ]
    Number of participants with photographs taken
  • · 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
Not Provided
Not Provided
 
Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis
Double-Blind, Bilateral, Vehicle-Controlled, Randomized Trial of Neuroskin Forte to Relieve Symptoms of Dry Skin
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.
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).
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
  • Psoriasis
  • Eczema
  • 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
  • Active Comparator: 1
    bilateral comparison
    Intervention: Drug: Neuroskin Forte
  • Placebo Comparator: 2
    bilateral comparison
    Intervention: Drug: Placebo Application
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
February 2010
February 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00143819
5494
No
Not Provided
Not Provided
Not Provided
University of Medicine and Dentistry of New Jersey
University of Medicine and Dentistry of New Jersey
AVVAA World Healthcare Products, Inc.
Principal Investigator: Melissa Magliocco, MD Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
April 2017

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