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Halobetasol (Halobetasol Propionate Topical) - Summary



Halobetasol propionate cream, 0.05% 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.

HALOBETASOL (Halobetasol) is indicated for the following:

Halobetasol propionate cream, 0.05% is a super-high potency corticosteroid indictated 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 corticosteroid, 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 Halobetasol (Halobetasol Propionate Topical)

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Ammonium Lactate Lotion 12% and Halobetasol Propionate Ointment 0.05% in the Treatment and Maintenance of Psoriasis. [2011.02]
Consensus recommends a gradual reduction in the frequency or steroid potency of topical corticosteroids following clinical improvement in the treatment of psoriasis, although no established guidelines have been developed... Combination treatment effectively cleared plaque psoriasis initially, and ammonium lactate twice daily everyday with weekend-only applications of halobetasol ointment effectively sustained the initial improvement for a significantly longer period of time when compared with placebo without demonstrating any significant side effects, such as steroid atrophy.

The efficacy of three class I topical synthetic corticosteroids, fluocinonide 0.1% cream, clobetasol 0.05% cream and halobetasol 0.05% cream: a Scholtz-Dumas bioassay comparison. [2009.08]
BACKGROUND: This study compared the efficacy of a novel, topical class I synthetic, 0.10% fluocinonide corticosteroid with two other class I corticosteroids and placebo for the treatment of plaque psoriasis... CONCLUSION: The three class I corticosteroid products were comparably effective, numerically and statistically, in clearing the psoriatic plaques. Upon completion of treatment, 60-80% of active-treated sites were clear or almost clear of psoriasis compared to zero with the placebo.

Topical halobetasol propionate in the treatment of plaque psoriasis: a review. [2005]
Halobetasol propionate (HP) 0.5% ointment and cream are class I topical corticosteroids. We review the efficacy and tolerability of HP for treatment of plaque psoriasis in the English language literature... Combination therapy with calcipotriene (calcipotriol) and tazarotene appears to be superior to monotherapy with topical HP.

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Clinical Trials Related to Halobetasol (Halobetasol Propionate Topical)

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.

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.).

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.

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

Randomized Study to Compare the Bioavailability of Three Halobetasol Propionate 0.05% Topical Creams [Completed]
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.

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Page last updated: 2011-12-09

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