CLOBEX SHAMPOO SUMMARY
CLOBEX™ (clobetasol propionate) Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.
CLOBEX™ (clobetasol propionate) Shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older (see PRECAUTIONS). Treatment should be limited to 4 consecutive weeks because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week (see DOSAGE and ADMINISTRATION).
Patients should be instructed to use CLOBEX™ Shampoo, 0.05%, for the minimum time period necessary to achieve the desired results (see PRECAUTIONS).
Use in patients younger than 18 years of age is not recommended due to numerically high rates of HPA axis suppression (see PRECAUTIONS, Pediatric Use).
There were insufficient numbers of non-Caucasian patients to determine whether they responded differently than Caucasian patients with regards to efficacy and safety.
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NEWS HIGHLIGHTS
Published Studies Related to Clobex Shampoo (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...
Short-contact clobetasol propionate shampoo 0.05% improves quality of life in patients with scalp psoriasis. [2009.03]
Scalp psoriasis has a considerable impact on the quality of life (QOL) of patients, and most patients are dissatisfied with available treatments. Clobetasol propionate shampoo 0.05% has been shown to be effective and safe for moderate to severe scalp psoriasis... Therefore, we conclude that treatment with clobetasol propionate shampoo improved the QOL of participants and resulted in high satisfaction.
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...
Clinical Trials Related to Clobex Shampoo (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.
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.
Efficacy, Safety, Preference and Response Duration of Clobex® Spray and Taclonex® Ointment in Psoriasis [Completed]
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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Page last updated: 2009-10-20
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