Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis
This study has been completed.
Sponsor:
University of Medicine and Dentistry New Jersey
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
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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 University of Medicine and Dentistry 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 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 University of Medicine and Dentistry 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 May 23, 2013