Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis

Phase 2

Terminated

• Conditions: Eczema; Psoriasis
• Interventions: Drug: Neuroskin Forte; Drug: Placebo Application

• Registration Number: NCT00143819
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

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).

Study Timeline

• Study First Submitted: 2005-08-31
• Study Start: 2005-09
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2017-01-04
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-07
• Last Update Submitted: 2017-04-07
• Results First Posted: 2017-04-25
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Neuroskin Forte	bilateral comparison
2	Placebo Application	bilateral comparison

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Visual Analog Scale (VAS) Score for Pruritus (Itching) at 8 Weeks	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

Name	Time	Method
Number of Participants With a Psoriasis ½-Body Physician Global Assessment (PGA) Improvement of at Least 2 Levels	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	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	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	8 weeks	Number of participants with photographs taken