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| ID | Type | Description | Link |
|---|---|---|---|
| H5939-34434-01 |
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This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy of once daily versus twice daily application of Ultravate® ointment (halobetasol propionate 0.05% ointment) in combination with Lac-Hydrin lotion (ammonium lactate topical) in the treatment of stable plaque psoriasis. 1) Phase 1: Patients will be treated for two weeks with combination therapy using Ultravate® ointment with Lac-Hydrin lotion and their psoriasis plaques will be evaluated to test efficacy of the medication. Half the subjects will be randomized to receive treatment with once a day Ultravate® ointment and twice daily Lac-Hydrin lotion; the other half of subjects will receive twice daily Ultravate® ointment with twice daily Lac-Hydrin lotion. Ultravate® ointment will be discontinued following two weeks of treatment, in compliance with its FDA indication. Phase 2: The second treatment phase will consist of a four-week observation period. Subjects will be re-randomized to either continue using twice daily Lac-Hydrin lotion, versus no treatment. The purpose of this second phase of the study is to investigate whether use of Lac-Hydrin monotherapy twice daily can minimize risk of recurrence and maximize duration of therapeutic effect. Part of this clinical study consists of the use of patient and physician satisfaction questionnaires. These questionnaires will include questions about the satisfaction with the formulation of each agent, questions about compliance with treatment, etc. Such questions could be used to demonstrate patient and physician satisfaction with each agent, with combination therapy, and to compare patient satisfaction rates among those randomized to once daily versus twice daily application of Ultravate® ointment. The hypothesis is that Ultravate ointment once daily in combination with Lac-Hydrin twice daily is equal in efficacy to Ultravate ointment twice daily in combination with Lac-Hydrin twice daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Twice Daily Ultravate | Active Comparator | Patients will apply both Ultravate ointment and LacHydrin lotion twice daily |
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| Once daily Ultravate | Active Comparator | Patients will apply Ultravate ointment once daily, but will use LacHydrin lotion twice daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultravate ointment twice daily + LacHydrin lotion twice daily | Drug | Topical corticosteroid |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Psoriasis Area Severity Index (PASI) Score | PASI is a scale that measures psoriasis severity based on erythema, induration, scaling, and body surface area covered. It ranges from 0 (no disease) to 72 (most extensive). | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tina Bhutani, MD | UCSF Clinical Fellow | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Psoriasis and Skin Treatment Center | San Francisco | California | 94118 | United States |
Patients were required to have a 2 week washout from topicals, 1 month washout from any systemic agents.
Patients were recruited from our medical clinic as well as through flyers posted at other University of California at San Francisco sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Twice Daily Topical Ultravate Ointment + LacHyrin Twice Daily | |
| FG001 | Once Daily Topical Ultravate Ointment + LacHydrin Lotion | |
| FG002 | Lac-Hydrin Topically Twice a Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Ultravate ointment once daily + LacHydrin lotion twice daily | Drug | Topical corticosteroid |
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| FG003 | No Treatment |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultravate Twice a Day | |
| BG001 | Ultravate Once a Day | Ultravate ointment applied once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Modified Psoriasis Area Severity Index (PASI) Score | PASI is a scale that measures psoriasis severity based on erythema, induration, scaling, and body surface area covered. It ranges from 0 (no disease) to 72 (most extensive). | This was a pilot study and the number was based on the available budget to perform the study. | Posted | Mean | Full Range | units on a scale | 2 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 | Ultravate Twice a Day | 0 | 20 | 0 | 20 | |||
| EG001 | Ultravate Once a Day | Ultravate ointment applied once daily | 0 | 20 | 0 | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Koo, Principle Investigator | UCSF | 415-476-4701 | john.koo@ucsfmedctr.org |
| Male |
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