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CLINICAL TRIALS PROFILE FOR HALOBETASOL PROPIONATE

All Clinical Trials for Halobetasol Propionate

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00715975	Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis	Completed	Azidus Brasil	Phase 2/Phase 3	2008-07-01	The Psoriasis and a chronic dermatosis characterized by abnormal proliferation of cells epithelial, vessel dilation and inflammation locally, which presents erythematous-scaly lesions in various areas of the body, preferably in the scalp, region and religious joints as elbows and knees. It occurs equally in both sexes and can appear at any age, and the mean age for the onset of the disease and around 27.3 years. The halobetasol propionate and an ultra-potent corticoid. Its chemical structure and similar to the Clobetasol corticoid this, until then classified as the most potent corticoid used worldwide in clinical practice. However, the molecular structure of Halobetasol gives it increased its activity antiinflammatory and anti-proliferative. The objective of this study is evaluating the efficacy and tolerability of the drug Halobetasol propionate cream formulation as a treatment in patients with plaque psoriasis mild to moderate, compared to the substance of similar power, Clobetasol propionate - Psorex - Cream.
NCT00802958	Randomized Study to Compare the Bioavailability of Two Halobetasol Propionate 0.05% Topical Ointments	Completed	Perrigo Company	N/A	2003-07-01	The purpose of this study was to compare the relative vasoconstrictive effects of test and reference Halobetasol Propionate 0.05% Ointment in healthy, female subjects.
NCT00803166	Randomized Study to Compare the Bioavailability of Three Halobetasol Propionate 0.05% Topical Creams	Completed	Perrigo Company	N/A	2004-01-01	The purpose of this study was to compare the relative vasoconstrictive effects of two test and one reference Halobetasol Propionate 0.05% Cream in healthy, female subjects.
NCT00865267	The Dose-response Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects	Completed	Actavis Inc.	Phase 1	2003-12-01	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	2003-12-01	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	2009-07-01	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	2009-01-01	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.
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