Back to resultsNeuroskin Forte for Dry Skin Relief in Eczema and Psoriasis
Primary Purpose
Psoriasis, Eczema
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Neuroskin Forte
Placebo Application
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, dry skin, eczema, atopic dermatitis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
bilateral comparison
bilateral comparison
Outcomes
Primary Outcome Measures
Change From Baseline in the Visual Analog Scale (VAS) Score for Pruritus (Itching) at 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
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
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
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
Number of participants with photographs taken
Full Information
NCT ID
NCT00143819
First Posted
August 31, 2005
Last Updated
April 7, 2017
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
AVVAA World Healthcare Products, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00143819
Brief Title
Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis
Official Title
Double-Blind, Bilateral, Vehicle-Controlled, Randomized Trial of Neuroskin Forte to Relieve Symptoms of Dry Skin
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
AVVAA World Healthcare Products, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Eczema
Keywords
psoriasis, dry skin, eczema, atopic dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
bilateral comparison
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
bilateral comparison
Intervention Type
Drug
Intervention Name(s)
Neuroskin Forte
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo Application
Intervention Description
Subjects will apply placebo sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in the Visual Analog Scale (VAS) Score for Pruritus (Itching) at 8 Weeks
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With a Psoriasis ½-Body Physician Global Assessment (PGA) Improvement of at Least 2 Levels
Description
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.
Time Frame
8 weeks
Title
Number of Participants With an Eczema ½-Body Investigator Global Assessment (IGA) Improvement of at Least 2 Levels
Description
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.
Time Frame
8 weeks
Title
Change in Target Lesion Scoring
Description
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.
Time Frame
8 weeks
Title
Photography of Target Lesions
Description
Number of participants with photographs taken
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Magliocco, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis
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