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Ultravate (Halobetasol Propionate Topical) - Summary



Ultravate® contains halobetasol propionate, a synthetic corticosteroid for topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti-inflammatory and antipruritic agent.

Ultravate is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

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Published Studies Related to Ultravate (Halobetasol Topical)

Calcipotriene ointment and halobetasol ointment in the long-term treatment of psoriasis: effects on the duration of improvement. [1998.09]
CONCLUSION: The addition of calcipotriene ointment applied on weekdays to a weekend pulse therapy regimen of superpotent corticosteroids can increase the duration of remission of psoriasis.

Double-blind bilateral paired comparison of 0.05% halobetasol propionate cream and its vehicle in patients with chronic atopic dermatitis and other eczematous dermatoses. [1991.12]
Six investigators evaluated 0.05% halobetasol propionate cream and its vehicle in 111 patients with chronic atopic dermatitis and several other eczematous dermatoses. Patients applied treatment twice daily to bilateral lesions for 14 days.

A review of two controlled multicenter trials comparing 0.05% halobetasol propionate ointment to its vehicle in the treatment of chronic eczematous dermatoses. [1991.12]
The efficacy and safety of 0.05% halobetasol propionate ointment were evaluated in patients with chronic atopic or other eczematous dermatoses in two vehicle-controlled, double-blind studies: a paired-comparison study in 124 patients (study A) and a parallel-group study in 100 patients (study B)...

A double-blind, vehicle-controlled paired comparison of halobetasol propionate cream on patients with plaque psoriasis. [1991.12]
The efficacy and safety of halobetasol propionate 0.05% cream, an ultra high-potency corticosteroid preparation, was evaluated in a double-blind, vehicle-controlled, paired comparison study. Patients' psoriatic lesions were evaluated before treatment and after 1 and 2 weeks of twice-daily treatment with halobetasol propionate and vehicle...

Evaluation of halobetasol propionate ointment in the treatment of plaque psoriasis: report on two double-blind, vehicle-controlled studies. [1991.12]
The results of two studies are presented that reveal the efficacy and safety of 0.05% halobetasol ointment in the treatment of patients with plaque psoriasis of at least moderate severity. Both multicenter studies were randomized, double-blind, and vehicle controlled, and study medications were applied twice daily for 2 weeks...

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Clinical Trials Related to Ultravate (Halobetasol Topical)

Comparing the Efficacy of Ultravate Ointment in Combination With Lac-Hydrin Lotion in the Treatment of Psoriasis [Completed]
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.

Pivotal Bioequivalence Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects [Completed]
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.).

Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis [Completed]
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.

The Dose-response Study of Topically Delivered Halobetasol Propionate Ointment in Normal Skin in Healthy Adult Subjects [Completed]

Ammonium Lactate Lotion 12% (Lac-hydrin«) and Halobetasol Propionate Ointment 0.05% (Ultravate«) in the Treatment and Maintenance of Psoriasis [Completed]
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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Page last updated: 2008-08-10

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