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The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp psoriasis.
This randomized, double-blind, vehicle-controlled, dose-ranging, parallel-group multi-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS, for the treatment of moderate to severe scalp psoriasis at different application times up to 30 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSXS1411 | Experimental | DSXS applied once a day for a total of 28 days. |
|
| Placebo | Placebo Comparator | Placebo (vehicle) applied once a day for a total of 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSXS1411 | Drug | DSXS (Taro Pharmaceuticals Inc.) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response of Success | The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1. | 28 Days |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | DSXS1411 5 Min | DSXS applied once a day for a total of 28 days for duration of 5 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) |
| FG001 | Placebo 5 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 5 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) |
| FG002 | DSXS1411 10 Min | DSXS applied once a day for a total of 28 days for duration of 10 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) |
| FG003 | Placebo 10 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 10 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) |
| FG004 | DSXS1411 15 Min | DSXS applied once a day for a total of 28 days for duration of 15 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) |
| FG005 | Placebo 15 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 15 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) |
| FG006 | DSXS1411 30 Min | DSXS applied once a day for a total of 28 days for duration of 30 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) |
| FG007 | Placebo 30 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 30 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DSXS1411 5 Min | DSXS applied once a day for a total of 28 days for duration of 5 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) |
| BG001 | Placebo 5 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 5 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Clinical Response of Success | The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1. | Posted | Count of Participants | Participants | 28 Days |
|
5 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 | DSXS1411 5 Min | DSXS applied once a day for a total of 28 days for duration of 5 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue 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 |
| 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 (vehicle) (Taro Pharmaceuticals Inc.) |
|
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
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| Progressive Disease |
|
| BG002 | DSXS1411 10 Min | DSXS applied once a day for a total of 28 days for duration of 10 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) |
| BG003 | Placebo 10 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 10 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) |
| BG004 | DSXS1411 15 Min | DSXS applied once a day for a total of 28 days for duration of 15 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) |
| BG005 | Placebo 15 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 15 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) |
| BG006 | DSXS1411 30 Min | DSXS applied once a day for a total of 28 days for duration of 30 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) |
| BG007 | Placebo 30 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 30 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Time Patient has Suffered from Symptoms | Count of Participants | Participants |
|
| DSXS1411 10 Min |
DSXS applied once a day for a total of 28 days for duration of 10 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) |
| OG003 | Placebo 10 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 10 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) |
| OG004 | DSXS1411 15 Min | DSXS applied once a day for a total of 28 days for duration of 15 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) |
| OG005 | Placebo 15 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 15 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) |
| OG006 | DSXS1411 30 Min | DSXS applied once a day for a total of 28 days for duration of 30 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) |
| OG007 | Placebo 30 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 30 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 4 |
| 24 |
| EG001 | Placebo 5 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 5 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) | 0 | 12 | 0 | 12 | 3 | 12 |
| EG002 | DSXS1411 10 Min | DSXS applied once a day for a total of 28 days for duration of 10 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) | 0 | 26 | 0 | 26 | 3 | 26 |
| EG003 | Placebo 10 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 10 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) | 0 | 12 | 0 | 12 | 3 | 12 |
| EG004 | DSXS1411 15 Min | DSXS applied once a day for a total of 28 days for duration of 15 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) | 0 | 22 | 0 | 22 | 4 | 22 |
| EG005 | Placebo 15 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 15 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) | 0 | 12 | 0 | 12 | 4 | 12 |
| EG006 | DSXS1411 30 Min | DSXS applied once a day for a total of 28 days for duration of 30 minutes. DSXS1411: DSXS (Taro Pharmaceuticals Inc.) | 0 | 25 | 0 | 25 | 7 | 25 |
| EG007 | Placebo 30 Min | Placebo (vehicle) applied once a day for a total of 28 days for duration of 30 minutes. Placebo: Placebo (vehicle) (Taro Pharmaceuticals Inc.) | 0 | 15 | 0 | 15 | 5 | 15 |
| Alanine aminotransferase increased | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Application site pain | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Application site pruritis | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Blood glucose increased | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Ear infection | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
|
| Ear swelling | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Foot fracture | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Hepatic enzyme increased | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
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