Eczema, Psoriasis
Conditions
Keywords
psoriasis, dry skin, eczema, atopic dermatitis
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).
Interventions
DRUGNeuroskin 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
Subjects will apply placebo sprays 3 times a day (with optional 4th application) to the assigned, randomized sides of the body for 8 weeks
Sponsors
AVVAA World Healthcare Products, Inc.
University of Medicine and Dentistry of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| Bilateral Comparison Group 2 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 | 8 |
| Total | 13 |
Baseline characteristics
| Characteristic | Bilateral Comparison Group 2 | Bilateral Comparison Group 1 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 3 Participants | 8 Participants |
| Age, Continuous | 61 years | 66 years | 63 years |
| Region of Enrollment United States | 8 participants | 5 participants | 13 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuroskin Forte Spray | Change From Baseline in the Visual Analog Scale (VAS) Score for Pruritus (Itching) at 8 Weeks | -52.2 percent change | Standard Deviation 34.6 |
| Placebo Spray | Change From Baseline in the Visual Analog Scale (VAS) Score for Pruritus (Itching) at 8 Weeks | -36.2 percent change | Standard Deviation 28.5 |
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuroskin Forte Spray | Change in Target Lesion Scoring | -20.7 percent change | Standard Deviation 27.5 |
| Placebo Spray | Change in Target Lesion Scoring | -14.7 percent change | Standard Deviation 11.7 |
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neuroskin Forte Spray | Number of Participants With an Eczema ½-Body Investigator Global Assessment (IGA) Improvement of at Least 2 Levels | 1 Participants |
| Placebo Spray | Number of Participants With an Eczema ½-Body Investigator Global Assessment (IGA) Improvement of at Least 2 Levels | 0 Participants |
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.
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neuroskin Forte Spray | Number of Participants With a Psoriasis ½-Body Physician Global Assessment (PGA) Improvement of at Least 2 Levels | 0 Participants |
| Placebo Spray | Number of Participants With a Psoriasis ½-Body Physician Global Assessment (PGA) Improvement of at Least 2 Levels | 0 Participants |
Secondary
Photography of Target Lesions
Number of participants with photographs taken
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neuroskin Forte Spray | Photography of Target Lesions | 13 Participants |
| Placebo Spray | Photography of Target Lesions | 13 Participants |