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| Name | Class |
|---|---|
| Sun Pharmaceutical Industries, Inc. | INDUSTRY |
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A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis
All patients will receive Topicort® twcie daily (BID) for 4 weeks. After week 4 patients will receive Topicort® twice weekly (on consecutive days) for 12 weeks, Patients will treat other body areas affected by plaque psoriasis with Topicort® during the study period (excludes face, groin, axilla)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open label | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topicort Topical Spray | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (Scalp Only) | Scalp psoriasis severity scale (score 0-4 where 0 is no psoriasis and 4 is severe) | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | United States |
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Of the 21 patients screened for participation, 20 subjects were enrolled to receive Open Label Topicort Topical Spray
Participants were recruited from private practice dermatology
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| ID | Title | Description |
|---|---|---|
| FG000 | Topicort Topical Spray | Topicort Topical 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 | Topicort Topical Spray | Topicort Topical Spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Investigator Global Assessment (Scalp Only) | Scalp psoriasis severity scale (score 0-4 where 0 is no psoriasis and 4 is severe) | Posted | Mean | Full Range | score on a scale | 16 weeks |
|
|
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 | Topicort Topical Spray | Topicort Topical Spray applied BID for 4 weeks followed by BID on 2 consecutive days through week 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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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 5, 2016 | Apr 6, 2018 | 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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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 20 |
| 0 |
| 20 |
| 9 |
| 20 |
| burning | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| sinusitis | Infections and infestations | Non-systematic Assessment |
|
| worsening of psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Infected lesion | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| worsening of anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| tinea | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| folliculitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| COPD | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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