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Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSXS topical product | Experimental | DSXS Active treatment |
|
| Placebo topical product | Placebo Comparator | Placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSXS | Drug | Active treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients in Each Treatment Group That Have Clinical Success | Clinical Success defined using the following scores at Visit 4 (Day 28 ± 2): At least a 2-grade improvement from the baseline IGA score (i.e., clear [0] or almost clear [1]) AND A score of clear or mild (0 or 1) for both erythema and induration/papulation/edema | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in %BSA Affected at Day 28 ± 2 | The change in %BSA Affected from Visit 1 Baseline (Day 1) to Visit 4 End of Treatment (Day 28 ± 2) | 28 days |
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Inclusion Criteria:
- male and non-pregnant females, age 6 months or older, with a confirmed diagnosis of moderate to severe atopic dermatitis (AD)
Exclusion Criteria:
- Lacks stable diagnosis of atopic dermatitis or has been diagnosed with mild atopic dermatitis.
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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 Product | Desoximetasone (DSXS) Active treatment DSXS: Active treatment |
| FG001 | Placebo Topical Product | Placebo treatment Placebo: Placebo treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DSXS Topical Product | DSXS Active treatment DSXS: Active treatment |
| BG001 | Placebo Topical Product | Placebo treatment Placebo: Placebo 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 | The Number of Patients in Each Treatment Group That Have Clinical Success | Clinical Success defined using the following scores at Visit 4 (Day 28 ± 2): At least a 2-grade improvement from the baseline IGA score (i.e., clear [0] or almost clear [1]) AND A score of clear or mild (0 or 1) for both erythema and induration/papulation/edema | Posted | Count of Participants | Participants | 28 days |
|
1 year, 4 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 Product | DSXS Active treatment DSXS: Active treatment | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal 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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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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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 |
|
|
| 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 |
|
| Baseline Total Body Surface Area (BSA) | Mean | Standard Deviation | meters squared |
|
| %BSA Affected with Atopic Dermatitis (AD) | Mean | Standard Deviation | percent |
|
| Baseline Investigator Global Assessment (IGA) Score | Count of Participants | Participants |
|
| Eczema Area and Severity Index (EASI) Score | The EASI is a composite score based on the severity of four different signs of atopic dermatitis (Erythema, Induration/Papulation/Edema, Lichenification, and Excoriation rated 0 to 3 in severity) in four different areas of the body (Head/Neck, Upper Limbs, Trunk, Lower Limbs) multiplied by the percent of that specific body area affected multiplied by a weighting factor. The minimum score would be 0 and the maximum score would be 72. To be eligible for participation in this study a patient must have an EASI of at least 15 at baseline. A higher EASI value represents a more severe case of eczema. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change From Baseline in %BSA Affected at Day 28 ± 2 | The change in %BSA Affected from Visit 1 Baseline (Day 1) to Visit 4 End of Treatment (Day 28 ± 2) | Posted | Least Squares Mean | Standard Error | percentage of BSA | 28 days |
|
|
|
|
| 61 |
| 0 |
| 61 |
| 8 |
| 61 |
| EG001 | Placebo Topical Product | Placebo treatment Placebo: Placebo treatment | 0 | 63 | 0 | 63 | 13 | 63 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Application site pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Spider vein | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |