Clobex® (clobetasol propionate) Shampoo, 0.05

Clobex® (clobetasol propionate) Shampoo, 0.05%

Indicated for the treatment of moderate to severe plaque psoriasis of the scalp in patients 18 years of age or older.

Clobex® Shampoo, 0.05%

Product Information

Indication, Dosage, Use

Indication

Clobex® 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. Treatment should be limited to 4 consecutive weeks because of the potential for the drug to suppress the hypothalmic-pituitary axis (HPA).1

Dosage

The total dosage should not exceed 50 g (50 mL or 1.75 fl oz) per week. Patients should be instructed to use Clobex® Shampoo, 0.05%, for the minimum time period necessary to achieve the desired results. Use in patients younger than 18 years of age is not recommended due to numerically high rates of HPA suppression.1

Use

Clobex® Shampoo, 0.05%, should be applied to affected areas of the scalp once daily. Do not wet hair before using Clobex® Shampoo. Leave Clobex® Shampoo in place for 15 minutes before adding water, lathering and rinsing hair and scalp completely. Clobex® Shampoo should not be used on the face, groin or axillae. Contact with the eyes and lips should be avoided.1

Lather, rinse, relief with Clobex® Shampoo, the Only Class 1 Shampoo formulation

Click here for full Prescribing Information for Clobex® Shampoo.

Reference:
  1. Clobex® Shampoo Prescribing Information. October 2008. Galderma Laboratories, L.P.

Phase 3 Clinical Studies

Clobex® Shampoo significantly reduced itchy, flaky symptoms of scalp psoriasis in a 4-week study1*

Patients with none to mild scalp psoriasis symptoms after 4 weeks of treatment 1*

*A 4-week, multicenter, randomized, vehicle-controlled, double-masked, parallel-group study to assess the efficacy and safety of Clobex® Shampoo, 0.05%, and its vehicle in patients with moderate to severe scalp psoriasis (N=142).

The primary endpoint of the study was Global Severity Score (GSS) after 4 weeks of treatment. Treatment success was defined as clear or minimal on the GSS. There was a statistically significant difference in proportion of patients who achieved treatment success at 4 weeks, favoring the Clobex® Shampoo group over the vehicle shampoo group (42.1% Clobex® Shampoo vs 2.1% vehicle shampoo; P<.001).1,2

Adverse events reported in this study were skin burning and skin irritation. The adverse events reported in all phase 2 and phase 3 clinical studies evaluating Clobex® Shampoo include burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia. The adverse events reported in phase 2 and phase 3 Clobex® Shampoo clinical studies that occurred at a rate of more than 1% in Clobex® Shampoo treatment groups include AEs on skin and appendages (8.8%), skin discomfort (4.7%), headache (1.8%); AEs reported on the body as a whole (5.9%).

Click here for full Prescribing Information for Clobex® Shampoo.

References:
  1. Jarratt M, Breneman D, Gottlieb AB, Poulin Y, Liu Y, Foley V. Clobetasol propionate shampoo 0.05%: a new option to treat patients with moderate to severe scalp psoriasis. J Drugs Dermatol. 2004;3:367-373.
  2. Clobex® Shampoo Prescribing Information. October 2008. Galderma Laboratories, L.P.

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Clobex Shampoo, 0.05%, Webinar

Valerie Callender, MD
Clinical Assistant Professor of Dermatology
Howard University College of Medicine
Washington, DC

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