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| Name | Class |
|---|---|
| Sun Pharmaceutical Industries, Inc. | INDUSTRY |
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A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks
A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks.
Adult male and female subjects with moderate to severe chronic plaque psoriasis All patients will receive Topicort® BID for 4 weeks.
After week 4 patients will receive Topicort® BID on two consecutive days a week for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open label | Experimental | Topicort topical spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topicort Topical Spray | Drug | open label Topicort spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Severity | Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Severity | Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis | 16 weeks |
| Psoriasis Severity | Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area. |
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Inclusion Criteria:
Exclusion Criteria:
>5% Body Surface Area
Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
Pregnant or breast feeding, or considering becoming pregnant during the study.
Malignancy or history of malignancy, except for:
Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
Patient received UVB phototherapy within 2 weeks of Baseline.
Patient received PUVA phototherapy within 4 weeks of Baseline.
Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in the label.
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| Name | Affiliation | Role |
|---|---|---|
| Jerry Bagel, MD | Director | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topicort Topical Spray | Topicort spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label | Topicort topical spray Topicort Topical Spray: open label Topicort spray applied twice daily for 4 weeks followed by twice daily BID on two consecutive days a week (e.g. Saturday and Sunday) for 12 weeks. |
| 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 | Psoriasis Severity | Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
|
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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 | Open Label | Topicort topical spray Topicort Topical Spray: open label Topicort spray |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| worsening of psoriasis | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerry Bagel Director of Clinical Trials | Psoriasis Treatment Center of Central New Jersey | 6094434500 | dreamacres1@aol.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2016 | Mar 18, 2024 | Prot_SAP_000.pdf |
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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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| 16 weeks |
| Dermatology Life Quality Index | calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. | 16 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Psoriasis Severity | Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
|
|
| Secondary | Psoriasis Severity | Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area. | Posted | Mean | Standard Deviation | percentage of BSA | 16 weeks |
|
|
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| Secondary | Dermatology Life Quality Index | calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 7 |
| 20 |
| erythema multiforme | Skin and subcutaneous tissue disorders |
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| hypertension | Cardiac disorders |
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| sciatic neuralgia | Nervous system disorders |
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| cough/congestion | Infections and infestations |
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| hyperglycemia | Metabolism and nutrition disorders |
|
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