TEMOVATE E SUMMARY
TEMOVATE E (clobetasol propionate emollient cream) Emollient contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.
TEMOVATE E Emollient is a super-high potency cortico-steroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 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 pediatric patients under 12 years of age is not recommended.
In the treatment of moderate to severe plaque-type psoriasis, TEMOVATE E Emollient applied to 5% to 10% of body surface area can be used up to 4 consecutive weeks. The total dosage should not exceed 50 g/week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. Treatment beyond 4 consecutive weeks is not recommended. Patients should be instructed to use TEMOVATE E Emollient for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS and INDICATIONS AND USAGE). Use in pediatric patients under 16 years of age has not been studied.
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NEWS HIGHLIGHTS
Published Studies Related to Temovate E (Clobetasol Topical)
Effects of topical treatment with the raft modulator miltefosine and clobetasol in cutaneous mastocytosis: a randomized, double-blind, placebo-controlled trial. [2009.08.03]
Summary Background Mastocytosis is characterized by the accumulation and activation of mast cells in different organs, most commonly the skin. Miltefosine, a raft modulator, has recently been shown to inhibit the activation of mast cells and to reduce mast cell-driven skin inflammatory responses...
Valacyclovir and topical clobetasol gel for the episodic treatment of herpes labialis: a patient-initiated, double-blind, placebo-controlled pilot trial. [2009.03]
BACKGROUND: Treatment of herpes simplex labialis (HSL) has been associated with modest benefits. This difficulty results from the rapid resolution of the disease accomplished by the immune system, which narrows the window of therapeutic opportunity. The immune response is also responsible for important clinical manifestations, including oedema and pain. The dual role of immune responses (protection, pathology) is well recognized in other infectious diseases. The addition of corticosteroids to antimicrobial agents has been associated with improvement in some of these diseases. OBJECTIVE: We evaluated the combination of oral valacyclovir plus topical clobetasol compared to placebo for recurrent HSL... CONCLUSIONS: This pilot study supports the addition of topical corticosteroids to an oral antiviral agent for the treatment of HSL. Larger studies need to confirm the safety and efficacy of this approach.
Topical clobetasol in the treatment of atrophic-erosive oral lichen planus: a randomized controlled trial to compare two preparations with different concentrations. [2009.02]
Oral lichen planus (OLP) is a chronic inflammatory disease that can be painful, mainly in the atrophic and erosive forms. Numerous drugs have been used with dissimilar results, but most treatments are empirical and do not have adequate control groups or correct study designs...
Valacyclovir and topical clobetasol gel for the episodic treatment of herpes labialis: a patient-initiated, double-blind, placebo-controlled pilot trial. [2009.01.08]
Abstract Background Treatment of herpes simplex labialis (HSL) has been associated with modest benefits. This difficulty results from the rapid resolution of the disease accomplished by the immune system, which narrows the window of therapeutic opportunity...
Comparing clobetasol propionate 0.05% spray to calcipotriene 0.005% betamethasone dipropionate 0.064% ointment for the treatment of moderate to severe plaque psoriasis. [2009.01]
Topical corticosteroids are widely used in the treatment of psoriasis. This study was conducted to compare the efficacy and safety of clobetasol propionate (CP) 0.005% spray to calcipotriene 0.005%-betamethasome diproprionate 0.064% (C-BD) ointment in patients with moderate to severe plaque psoriasis...
Clinical Trials Related to Temovate E (Clobetasol Topical)
A Comparison Between Clobetasol Propionate 0.05% (Clobex®) Spray and Clobetasol Propionate 0.05% (Olux®) Foam [Completed]
Efficacy, Tolerance and Satisfaction With CLOBEX® Spray When Used as Monotherapy or Add-on Therapy in Plaque Psoriasis [Completed]
Evaluation of the effectiveness of Clobex® Spray, 0. 05% when used as monotherapy or add-on
therapy to existing systemic or topical anti-psoriatic agents.
Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis [Completed]
Maintenance Effect of Clobex Shampoo on Subjects With Moderate to Severe Scalp Psoriasis [Completed]
The objective of the study is to assess the maintenance effect on scalp psoriasis of Clobex®
Shampoo 0. 05% when used twice weekly.
Evaluate Safety/Efficacy of Two Treatment Regimens for Vectical™ Ointment & Clobex® Spray for Moderate Plaque Psoriasis [Not yet recruiting]
This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate)
Spray 0. 05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one
of two different regimens:
1. Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray treatment twice daily on weekends (Sat - Sun) for 28 days
2. Clobex® Spray each morning and Vectical™ Ointment once each evening for 28 days
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