Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis

Phase 2TerminatedNCT00143819

University of Medicine and Dentistry of New Jersey13 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Psoriasis Eczema

Interventions

Neuroskin ForteDRUG

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 ApplicationDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 8 weeks

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.

Time frame: 8 weeks

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.

Time frame: 8 weeks

Photography of Target Lesions

Number of participants with photographs taken

Time frame: 8 weeks

Data from ClinicalTrials.gov

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