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The purpose of this study is to determine whether Cloderm Cream is effective for topical treatment of moderate psoriasis over 28 days.
The objective of this study is to estimate the efficacy of Cloderm Cream for topical treatment of moderate plaque psoriasis over 28 days using current standards for evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cloderm Cream | Experimental | Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cloderm Cream | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Assessment (IGA) | The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1). | 28 days |
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Inclusion Criteria:
Subject understands the study procedures and agrees to participate by giving written informed consent.
Subjects must be at least 18 years of age.
Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
Subjects with psoriasis involving 2 to 20% BSA, not including the face, scalp and intertriginous areas.
Subjects must have an IGA Grade of 3 at the Baseline Visit.
Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (Visit 2) (test will have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) and practice a reliable method of contraception or remain sexually inactive throughout the study.
All women of childbearing potential must be willing to undergo a urine pregnancy test at Visit 2 (Day 0), at Visit 4 (Day 14), and at Visit 5 (Day 28).
Subjects must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne M Fraser, PhD | Promius Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research, Inc. | Cincinnati | Ohio | 45249 | United States | ||
| Oregon Medical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cloderm Cream | Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days Cloderm Cream |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cloderm Cream | Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days Cloderm Cream |
| 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 | Investigator's Global Assessment (IGA) | The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1). | Intent to treat population, with LOCF for missing data | Posted | Number | 95% Confidence Interval | percentage of subjects | 28 days |
|
|
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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 | Cloderm Cream | Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days Cloderm Cream |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Operations | Promius Pharma | 609-282-1404 | jfraser@drreddys.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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| Portland |
| Oregon |
| 97223 |
| United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Madison Skin and Research, Inc. | Madison | Wisconsin | 53719 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 60 |
| 0 |
| 60 |
No report, abstract, oral presentation, or publication proposed by the Investigator/Institution in regard to Study shall be presented or published without the prior written consent of the Sponsor. Sponsor reserves the right to comment on and delay the proposed report, abstract, oral presentation, or publication and to revise as necessary to protect confidential information or intellectual property.