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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
  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: Participant, 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 ( University of Medicine and Dentistry of New Jersey ):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00143819     History of Changes
Other Study ID Numbers: 5494
Study First Received: August 31, 2005
Results First Received: January 4, 2017
Last Updated: April 7, 2017

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
psoriasis
dry skin
eczema
atopic dermatitis

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

ClinicalTrials.gov processed this record on July 19, 2017