Neuroskin Forte for Dry Skin Relief in Eczema and Psoriasis
|ClinicalTrials.gov Identifier: NCT00143819|
Recruitment Status : Terminated (Low enrollment)
First Posted : September 2, 2005
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Eczema||Drug: Neuroskin Forte Drug: Placebo Application||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Double-Blind, Bilateral, Vehicle-Controlled, Randomized Trial of Neuroskin Forte to Relieve Symptoms of Dry Skin|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
Active Comparator: 1
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
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
- Change From Baseline in the Visual Analog Scale (VAS) Score for Pruritus (Itching) at 8 Weeks [ Time Frame: 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.
- Number of Participants With a Psoriasis ½-Body Physician Global Assessment (PGA) Improvement of at Least 2 Levels [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 8 weeks ]Number of participants with photographs taken
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143819
|Principal Investigator:||Melissa Magliocco, MD||Rutgers, The State University of New Jersey|