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| ID | Type | Description | Link |
|---|---|---|---|
| Study # 70915005 | Other Identifier | Novum |
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The objective of this study is to evaluate the potential of desoximetasone 0.25% topical spray to suppress HPA axis function. The potential for adrenal suppression will be assessed following multiple dosing with Desoximetasone 0.25% Topical Spray in patients with moderate to severe plaque psoriasis. The secondary objectives are to evaluate the efficacy parameters and to evaluate the adverse event (AE) profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psoriasis involving 10-15% BSA | Experimental | Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area. |
|
| Psoriasis involving >15% of BSA | Experimental | Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desoximetasone 0.25% spray | Drug | Desoximetasone spray applied to affected areas twice daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients in the Study With Hypothalamic Pituitary Adrenal (HPA) Axis Suppression | Each patient is assessed at Day 28. A cortisol response test performed at baseline are reevaluated at the conclusion of the study. If the normal cortisol response test measured at baseline is no long present the patient is considered to have demonstrated possible HPA axis suppression. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percent Body Surface Area (%BSA) Affected by Psoriasis | Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared %Body Surface Area Affected the "Rule of Nine" was be used |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Hot Springs | Arkansas | United States | |||
| Investigator Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Psoriasis Involving 10-15% BSA | Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days |
| FG001 | Psoriasis Involving >15% of BSA | Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Psoriasis Involving 10-15% BSA | Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area. Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 the Study With Hypothalamic Pituitary Adrenal (HPA) Axis Suppression | Each patient is assessed at Day 28. A cortisol response test performed at baseline are reevaluated at the conclusion of the study. If the normal cortisol response test measured at baseline is no long present the patient is considered to have demonstrated possible HPA axis suppression. | Posted | Number | participants | 28 days |
|
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 | Psoriasis Involving 10-15% BSA | Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adrenal Suppression | Endocrine 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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| ID | Term |
|---|---|
| D003899 | Desoximetasone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| 28 days |
| Change From Baseline in Physician's Global Assessment (PGA) Score for Psoriasis | The PGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration,erythema and scaling. The PGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe). | 28 days |
| Albuquerque |
| New Mexico |
| United States |
| Investigator Site | Simpsonville | South Carolina | United States |
| Psoriasis Involving >15% of BSA |
Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area. Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days |
|
|
|
| Secondary | Change From Baseline in Percent Body Surface Area (%BSA) Affected by Psoriasis | Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared %Body Surface Area Affected the "Rule of Nine" was be used | No statistical analysis provided for Percentage of Body Surface Area Affected by Psoriasis. As the study is not powered sufficiently to perform efficacy statistical analysis, descriptive statistical analysis are presented on the mean change from baseline in % BSA affected | Posted | Mean | Standard Deviation | percentage of Body Surface Area Affected | 28 days |
|
|
|
| Secondary | Change From Baseline in Physician's Global Assessment (PGA) Score for Psoriasis | The PGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration,erythema and scaling. The PGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe). | No statistical analysis provided for Percentage of Participants With a Physician's Global Assessment (PGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) | Posted | Mean | Standard Deviation | percentage of physician's global assessm | 28 days |
|
|
|
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | Psoriasis Involving >15% of BSA | Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days | 0 | 12 | 6 | 12 |
| Application Site Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Cyst | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Sciatica | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003907 | Dexamethasone |
| D013259 | Steroids, Fluorinated |