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A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III Clinical Study
This randomized, double-blind, vehicle-controlled, parallel-group multiple-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS 1535 product, for the treatment of mild to severe scalp psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSXS 1535 | Experimental | DSXS 1535 topical product |
|
| Placebo | Placebo Comparator | Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSXS | Drug | topical product |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success in Patients With Moderate and Severe Scalp Psoriasis | IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline | from baseline to study day 29 |
| Clinical Success in Patients With Mild to Severe Scalp Psoriasis | IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline | from baseline to study day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success in Patients With Mild Scalp Psoriasis | IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline | from baseline to study day 29 |
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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 |
| Natalie Yantovskiy | Taro Pharmaceuticals USA Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | DSXS 1535 | DSXS 1535 topical product DSXS: topical product |
| FG001 | Placebo | Vehicle Placebo: topical product |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DSXS 1535 | DSXS 1535 topical product DSXS: topical product |
| BG001 | Placebo | Vehicle Placebo: topical product |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Clinical Success in Patients With Moderate and Severe Scalp Psoriasis | IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline | Patients with moderate and severe scalp psoriasis (primary analysis 1) | Posted | Count of Participants | Participants | from baseline to study day 29 |
|
9 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 | DSXS 1535 | DSXS 1535 topical product DSXS: topical product | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear discomfort | Ear and labyrinth disorders | MedDRA (18.1) | 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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| Placebo |
| Drug |
topical product |
|
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Non-Compliance With Study Drug |
|
| Progressive Disease |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Percent Scalp Affected | Mean | Standard Deviation | percent |
|
| Number of months and/or years patient has suffered from symptoms caused by scalp psoriasis | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Clinical Success in Patients With Mild to Severe Scalp Psoriasis | IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline | Patients with mild to severe scalp psoriasis (primary analysis 2) | Posted | Count of Participants | Participants | from baseline to study day 29 |
|
|
|
|
| Secondary | Clinical Success in Patients With Mild Scalp Psoriasis | IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline | Posted | Count of Participants | Participants | from baseline to study day 29 |
|
|
|
|
| 180 |
| 0 |
| 180 |
| 46 |
| 180 |
| EG001 | Placebo | Vehicle Placebo: topical product | 0 | 189 | 0 | 189 | 43 | 189 |
| Ear pain | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (18.1) | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA (18.1) | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA (18.1) | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Epigastric discomfort | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Application site discomfort | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Application site dryness | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Application site dryness | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Application site pain | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Application site pruritus | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Xerosis | General disorders | MedDRA (18.1) | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA (18.1) | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Burns third degree | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
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