Clobex® (clobetasol propionate) Lotion, 0.05

Clobex® (clobetasol propionate) Lotion, 0.05%

Indicated for the 4-week treatment of moderate to severe plaque psoriasis and corticosteroid-responsive dermatoses in patients 18 years of age or older.

Clobex® Lotion, 0.05%

Product Information

Indication, Dosage, Use

Indication

Clobex® Lotion, 0.05%, is a super-high potent corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older. Treatment should be limited to 2 consecutive weeks. For the treatment of moderate to severe plaque psoriasis, localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment may be treated for up to 2 additional weeks.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® Lotion, 0.05%, for the minimum amount of time necessary to achieve the desired results. Use in patients younger than 18 years of age is not recommended.1

Use

Clobex® Lotion, 0.05%, should be applied twice a day, once in the morning and once at night. Clobex® Lotion should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin or axillae.1

Click here for full Prescribing Information for Clobex® Lotion.

Reference:
  1. Clobex® Lotion Prescribing Information. October 2005. Galderma Laboratories, L.P.

Phase 3 Study of Moderate to Severe Atopic Dermatitis

Clobex® (clobetasol propionate) Lotion, 0.05%, significantly reduces itching and inflammatory symptoms in patients with moderate to severe corticosteroid-responsive dermatoses1

The proportion of subjects who achieved Global Severity Score (GSS) "success" was significantly higher in the Clobex® Lotion group compared with the vehicle group (72.9% vs 36.4%; P=.001).1

GSS success rate at 2 weeks in patients with atopic dermatitis1*

*In a randomized study, 229 patients with moderate to severe atopic dermatitis applied treatment twice daily for 2 weeks. Ninety-six patients received Clobex® Lotion, 0.05%, and 33 patients received vehicle. The primary endpoint was success rate. Success rate was defined as GSS of 0, 0.5 or 1 (none to mild) and failure was defined as 2, 3 or 4 (moderate to severe).

Results at 2 weeks1,2

Results at 2 weeks1,2

Patient: AV 60767
Individual results may vary.

Unique lotion vehicle suited for eczematous or atopic skin
  • Easy to spread over larger surface areas
  • No alcohol, fragrances or preservatives to aggravate broken or fissured skin

In controlled clinical trials of Clobex® Lotion, the following adverse events have been reported: stinging/burning, skin dryness, irritation, erythema, folliculitis, pruritis, skin atrophy and telangiectasia. The pooled incidence of local adverse reactions in trials for psoriasis and atopic dermatitis at 1% or greater include skin atropy (4.2%), telangiectasia (3.2%), skin discomfort (1.3%) and dry skin (1.0%).3

Click here for full Prescribing Information for Clobex® Lotion.

References:
  1. Breneman D, Fleischer AB Jr, Kaplan D, et al. Clobetasol propionate 0.05% lotion in the treatment of moderate to severe atopic dermatitis: a randomized evaluation versus clobetasol propionate emollient cream. J Drugs Dermatol. 2005;4:330-336.
  2. Data on file. Galderma Laboratories.
  3. Clobex® Lotion Prescribing Information. October 2005. Galderma Laboratories, L.P.

Next: Data Library

Featured Presentation

Clobex® (clobetasol propionate) Lotion, 0.05%

Steven R. Feldman, MD, PhD
Professor of Dermatology
Center for Integrative Medicine,
Center for Worker Health Wake
Forest University School of Medicine
Department of Dermatology

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