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A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS topical product in Patients with Mild to Severe Scalp Psoriasis
To evaluate the therapeutic efficacy and safety of DSXS topical product (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Vehicle topical product (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to severe scalp psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSXS topical | Experimental | applied once daily for 28 days |
|
| Vehicle topical | Placebo Comparator | applied once daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSXS topical | Drug | topical treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success | Clinical Success is defined by an IGA score of 0 (clear) or I (almost clear) with at least a 2 grades reduction from baseline at Day 29 ± 2 | 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 |
| 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 | DSXS Topical | applied once daily for 28 days DSXS topical: topical treatment |
| FG001 | Vehicle Topical | applied once daily for 28 days Vehicle topical: topical treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DSXS Topical | applied once daily for 28 days DSXS topical: topical treatment |
| BG001 | Vehicle Topical | applied once daily for 28 days Vehicle topical: topical treatment |
| 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 | Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success | Clinical Success is defined by an IGA score of 0 (clear) or I (almost clear) with at least a 2 grades reduction from baseline at Day 29 ± 2 | Posted | Count of Participants | Participants | Day 29 |
|
8 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 Topical | applied once daily for 28 days DSXS topical: topical treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site dermatitis | General 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2016 | Oct 2, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 11, 2016 | Oct 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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| Vehicle topical | Drug | topical treatment |
|
|
| 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 |
|
| Region of Enrollment | Number | 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 |
|
|
|
| 0 |
| 183 |
| 0 |
| 183 |
| 31 |
| 183 |
| EG001 | Vehicle Topical | applied once daily for 28 days Vehicle topical: topical treatment | 0 | 183 | 0 | 183 | 42 | 183 |
| Application site dryness | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Application site exfoliation | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Application site hyperaesthesia | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Application site irritation | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Application site pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Application site paraesthesia | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (18.1) | Systematic Assessment |
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| Ocular icterus | Eye disorders | MedDRA (18.1) | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal 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 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
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