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Dow
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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR ULTRAVATE

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Clinical Trials for Ultravate

Trial ID Title Status Sponsor Phase Summary
NCT00865267 The Dose-response Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects Completed Actavis Inc. Phase 1 The purpose of this study is to determine the duration of application of halobetasol propionate 0.05% ointment to be used in a definitive study of bioequivalence of to formulations of this ointment. Part A: To validate vasoconstrictor assay precision. Part B: To evaluate the dose response vasoconstriction profile of Ultravate® 0.05% ointment at different dose durations over a short period of time (0.17 - 4 hrs).
NCT00865605 Pivotal Bioequivalence Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects Completed Actavis Inc. Phase 1 The purpose of this study is to compare the vasoconstriction response profile and bioequivalence between one innovator lot of Ultravate® 0.05% ointment and one test/generic lot of Halobetasol propionate 0.05% ointment (Alpharma USPD, Inc.).
NCT00990561 Comparing the Efficacy of Ultravate Ointment in Combination With Lac-Hydrin Lotion in the Treatment of Psoriasis Completed University of California, San Francisco Phase 4 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.
NCT01111123 Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis Completed Icahn School of Medicine at Mount Sinai Phase 4 The purpose of this study is to determine whether the combinational use of ammonium lactate lotion 12% (Lac-Hydrin) and halobetasol propionate ointment 0.05% (Ultravate) is safe and effective in the initial treatment and long-term maintenance of psoriasis. Patients will use both medications continuously for two weeks and those who obtain a good improvement based on investigator clinical assessments will be randomized to Lac-Hydrin lotion twice daily every day with placebo ointment or Ultravate ointment twice daily on weekends only for up to 24 more weeks.
NCT01166646 Blinded Study of Topical Investigational Lotion Vs. Approved Cream in Treatment of Plaque Psoriasis Completed Therapeutics, Inc. Phase 2 The purpose of this study is to determine whether the investigational lotion is an effective treatment of moderate to severe plaque psoriasis in comparison to an approved cream.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ultravate

Condition Name

Condition Name for Ultravate
Intervention Trials
Psoriasis 3
Plaque Psoriasis 2
Healthy 2
Stable Plaque Psoriasis 1
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Condition MeSH

Condition MeSH for Ultravate
Intervention Trials
Psoriasis 6
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Clinical Trial Locations for Ultravate

Trials by Country

Trials by Country for Ultravate
Location Trials
United States 31
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Trials by US State

Trials by US State for Ultravate
Location Trials
California 7
Texas 4
Florida 3
North Carolina 3
Indiana 2
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Clinical Trial Progress for Ultravate

Clinical Trial Phase

Clinical Trial Phase for Ultravate
Clinical Trial Phase Trials
Phase 4 2
Phase 2 3
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Ultravate
Clinical Trial Phase Trials
Completed 6
Recruiting 2
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Clinical Trial Sponsors for Ultravate

Sponsor Name

Sponsor Name for Ultravate
Sponsor Trials
Valeant Pharmaceuticals International, Inc. 3
Actavis Inc. 2
Icahn School of Medicine at Mount Sinai 1
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Sponsor Type

Sponsor Type for Ultravate
Sponsor Trials
Industry 6
Other 2
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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Boehringer Ingelheim
Fish and Richardson
Cerilliant
US Army
Harvard Business School
Citi
Cantor Fitzgerald
Covington

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