Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis

NCT00143819 | Terminated Phase 2 Results

• 1 other identifier: 5494
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis; Eczema

Keywords

psoriasis; dry skin; eczema; atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (4)

• Number of Participants With a Psoriasis ½-Body Physician Global Assessment (PGA) Improvement of at Least 2 Levels

  8 weeks

• Number of Participants With an Eczema ½-Body Investigator Global Assessment (IGA) Improvement of at Least 2 Levels

  8 weeks

• Change in Target Lesion Scoring

  8 weeks

• Photography of Target Lesions

  8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

bilateral comparison

Drug: Neuroskin Forte

2

PLACEBO COMPARATOR

bilateral comparison

Drug: Placebo Application

Interventions

Neuroskin Forte DRUG

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

1

Placebo Application DRUG

Subjects will apply placebo sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• AVVAA World Healthcare Products, Inc.: collaborator

MeSH Terms

Conditions

Psoriasis; Eczema; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Skin Diseases, Eczematous; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

small sample size

Results Point of Contact

• Title: Dr M Magliocco
• Organization: UMDNJ-Robert Wood Johnson Medical School

maglioma@yahoo.com

Study Officials

• Melissa Magliocco, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: September 1, 2005
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 25, 2017
• Results First Posted: April 25, 2017

Record last verified: 2017-04