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The objective of this study is to demonstrate that desoximetasone 0.25% topical spray is effective for the treatment of patients with moderate to severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desoximetasone Spray 0.25% | Experimental | Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days |
|
| placebo | Placebo Comparator | Placebo administered to affected area twice a day for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desoximetasone Spray 0.25% | Drug | Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success ITT | A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear). | 28 days |
| Treatment Success | A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS) for each the three signs and symptoms (erythema, scaling and plaque elevation). | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment (PGA) of Psoriasis Score at Day 28. | Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Hazleton | Pennsylvania | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Desoximetasone Spray 0.25% | Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days |
| FG001 | Placebo | Placebo administered to affected area twice a day for 28 days placebo: Placebo administered to affected area twice a day for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Desoximetasone Spray 0.25% | Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days |
| BG001 | Placebo |
| 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 ITT | A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear). | Analysis was conducted using Intent-to-Treat (ITT) | Posted | Number | participants | 28 days |
|
3 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 | Desoximetasone Spray 0.25% | Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Irritation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Taro Pharmaceuticals U.S.A., Inc. | 914-345-9001 | natalie.yantovskiy@taro.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| placebo | Drug | Placebo administered to affected area twice a day for 28 days |
|
| Day 28 |
Placebo administered to affected area twice a day for 28 days placebo: Placebo administered to affected area twice a day for 28 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Treatment Success | A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS) for each the three signs and symptoms (erythema, scaling and plaque elevation). | Posted | Number | participants | Day 28 |
|
|
|
|
| Secondary | Physician's Global Assessment (PGA) of Psoriasis Score at Day 28. | Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. | ITT Population. Participants who returned for at least one post baseline visit and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit. | Posted | Mean | Standard Deviation | units on a scale | Day 28 |
|
|
|
|
| 0 |
| 60 |
| 4 |
| 60 |
| EG001 | Placebo | Placebo administered to affected area twice a day for 28 days placebo: Placebo administered to affected area twice a day for 28 days | 0 | 60 | 5 | 60 |
| Application Site Pain | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
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