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The purpose of this study is to evaluate the therapeutic efficacy and safety of DSXS compared to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis.
To evaluate the therapeutic efficacy and safety of dsxs topical spray, 0.15% (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Placebo (vehicle) spray (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to moderate plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSXS1505 | Experimental | To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. |
|
| Placebo | Placebo Comparator | Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSXS | Drug | active treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 | The number of patients in each treatment group that have clinical success. Clinical Success is at least a 2-grade improvement from the baseline IGA score. The minimum IGA value is 0, and maximum value is 5. A higher number represents a more severe case of plaque psoriasis. Patients are required to have an IGA score of 2 or 3 at baseline, so all clinical success IGA scores will be either 0 or 1. | 28 Days |
| Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 | The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 3) | The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 3, so any IGA score of 0 or 1 at Day 28 ± 2 would be a treatment success. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novum Pharmaceutical Research Services | http://www.novumprs.com/contact | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taro Pharmaceuticals USA Inc. | Hawthorne | New York | 10532 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | DSXS1505 | To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. DSXS: active treatment Placebo: placebo treatment |
| FG001 | Placebo | Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. DSXS: active treatment Placebo: placebo treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | DSXS1505 | To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. DSXS: active treatment Placebo: placebo treatment |
| BG001 | Placebo | Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. DSXS: active treatment Placebo: placebo treatment |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 | The number of patients in each treatment group that have clinical success. Clinical Success is at least a 2-grade improvement from the baseline IGA score. The minimum IGA value is 0, and maximum value is 5. A higher number represents a more severe case of plaque psoriasis. Patients are required to have an IGA score of 2 or 3 at baseline, so all clinical success IGA scores will be either 0 or 1. | Posted | Count of Participants | Participants | 28 Days |
|
1 year, 7 months
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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 | DSXS1505 | To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. DSXS: active treatment Placebo: placebo treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalie Yantovskiy | Taro Pharmaceuticals U.S.A. Inc | +1 914-345-9001 | 6849 | Natalie.Yantovskiy@Taro.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2017 | Nov 2, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 4, 2016 | Nov 2, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Placebo | Drug | placebo treatment |
|
|
| 28 Days |
| Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 3) | The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. This measure is limited to patients with a baseline IGA score of 3. | 28 Days |
| Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 2) | The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 2, so only an IGA score of 0 at Day 28 ± 2 would be a treatment success. | 28 Days |
| Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 2) | The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. This measure is limited to patients with a baseline IGA score of 2. | 28 Days |
| Other Reasons |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Baseline Total BSA | Mean | Standard Deviation | meters squared |
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| %BSA Affected with Psoriasis | Mean | Standard Deviation | percent of BSA |
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| Baseline Investigator's Global Assessment (IGA) Score | IGA is an overall assessment of the severity of a patient's case of plaque psoriasis, rated 0 to 5 as detailed in Appendix C of the protocol. A higher value represents a more severe case of plaque psoriasis. | Count of Participants | Participants |
|
| Baseline Total Lesion Severity Score (TLSS) | TLSS is a lesion assessment to determine severity of a plaque psoriasis lesion based on a summation of scores Erythema, Scaling, and Plaque Elevation (each rated 0 to 5 in severity). This is detailed in Appendix B of the study protocol. The minimum value is 0, and the maximum value is 15. A higher value indicates a more severe plaque psoriasis lesion. To be considered for inclusion in the study, the Target Lesion must have a Plaque Elevation sub-scale score of at least 2. | Mean | Standard Deviation | units on a scale |
|
| Baseline Scaling Score | Count of Participants | Participants |
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| Baseline Erythema Score | Count of Participants | Participants |
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| Baseline Plaque Elevation | Count of Participants | Participants |
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| Baseline Psoriasis Area Severity Index (PASI) Score | The PASI is a composite score based on the severity of three different clinical signs of psoriasis (Erythema, Induration, and Scaling, each rated 0 to 4 in severity) in four different areas of the body (Head/Neck, Upper Limbs, Trunk, and Lower Limbs) multiplied by the percent of that specific body area affected multiplied by a weighting factor. The scale is explained in detail in the study protocol Appendix D. The minimum score would be 0 and the Maximum Score would be 72. A higher value would represent a more severe case of psoriasis. | Mean | Standard Deviation | units on a scale |
|
| Target Lesion Size (area) | Mean | Standard Deviation | centimeters squared |
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Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product.
DSXS: active treatment
Placebo: placebo treatment
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|
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| Primary | Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 | The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. | Posted | Count of Participants | Participants | 28 Days |
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| Secondary | Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 3) | The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 3, so any IGA score of 0 or 1 at Day 28 ± 2 would be a treatment success. | Posted | Count of Participants | Participants | 28 Days |
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| Secondary | Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 3) | The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. This measure is limited to patients with a baseline IGA score of 3. | Posted | Count of Participants | Participants | 28 Days |
|
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|
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| Secondary | Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 2) | The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 2, so only an IGA score of 0 at Day 28 ± 2 would be a treatment success. | Posted | Count of Participants | Participants | 28 Days |
|
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| Secondary | Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 2) | The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. This measure is limited to patients with a baseline IGA score of 2. | Posted | Count of Participants | Participants | 28 Days |
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| 0 |
| 60 |
| 0 |
| 60 |
| 3 |
| 60 |
| EG001 | Placebo | Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. DSXS: active treatment Placebo: placebo treatment | 0 | 59 | 0 | 59 | 3 | 59 |
| Application site pain | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Application site paraesthesia | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
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