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Low enrollment
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| Name | Class |
|---|---|
| AVVAA World Healthcare Products, Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | bilateral comparison |
|
| 2 | Placebo Comparator | bilateral comparison |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Magliocco, MD | Rutgers, The State University of New Jersey | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 (Left Side: Active; Right Side: Placebo) | bilateral comparison Subjects randomized to Group 1 applied Neuroskin Forte study drug sprays to the left side of the body and placebo sprays to the right side of the body, 3 times a day (with optional 4th application), for 8 weeks. |
| FG001 | 2 (Left Side: Placebo; Right Side: Active) | bilateral comparison Subjects randomized to Group 2 applied placebo sprays to the left side of the body and Neuroskin Forte study drug sprays to the right side of the body, 3 times a day (with optional 4th application), for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bilateral Comparison Group 1 | bilateral comparison 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 |
| BG001 | Bilateral Comparison Group 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body. | Posted | Mean | Standard Deviation | percent change | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bilateral Comparison: Neuroskin Forte Spray vs Placebo Spray | bilateral comparison Subjects were randomized to apply Neuroskin Forte study drug spray to one side of the body and placebo spray to the other side of the body, 3 times a day (with optional 4th application), for 8 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin infection | Infections and infestations |
small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr M Magliocco | UMDNJ-Robert Wood Johnson Medical School | maglioma@yahoo.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D004485 | Eczema |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003872 | Dermatitis |
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| 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 |
|
| 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. | 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. | 8 weeks |
| Photography of Target Lesions | Number of participants with photographs taken | 8 weeks |
bilateral comparison 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Placebo Spray |
bilateral comparison Subjects were randomized to apply placebo spray to one side of the body, 3 times a day (with optional 4th application), for 8 weeks. |
|
|
| Secondary | 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. | The eight (8) subjects in the study who had psoriasis were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | 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. | The five (5) subjects in the study who had eczema were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | 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. | Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body. | Posted | Mean | Standard Deviation | percent change | 8 weeks |
|
|
|
| Secondary | Photography of Target Lesions | Number of participants with photographs taken | Thirteen (13) subjects were randomized to receive Neuroskin Forte (ie, active) spray on one side of the body and placebo spray on the other side of the body. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 0 |
| 13 |
| 4 |
| 13 |
| increased itching | Skin and subcutaneous tissue disorders |
|
| cough | Respiratory, thoracic and mediastinal disorders |
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| pneumonia | Infections and infestations |
|
| increased severity of eczema | Skin and subcutaneous tissue disorders |
|
| upper respiratory infection | Infections and infestations |
|
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| D017443 | Skin Diseases, Eczematous |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |