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Clobex Shampoo (Clobetasol Propionate Topical) - Description and Clinical Pharmacology



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.

The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11(beta),17-dihydroxy-16(beta)-methylpregna-1, 4-diene-3, 20-dione 17-propionate. It has the following structural formula:

Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C25H32C1FO5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water.

Each mL of CLOBEX™ (clobetasol propionate) Shampoo, 0.05%, contains clobetasol propionate, 0.05%, in a shampoo base consisting of alcohol, citric acid, coco-betaine, polyquaternium-10, purified water, sodium citrate, and sodium laureth sulfate.


Like other topical corticosteroids, CLOBEX™ (clobetasol propionate) Shampoo, 0.05%, has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier and occlusion. Topical corticosteroids can be absorbed from normal intact skin, while inflammation and/or other disease processes in the skin may increase percutaneous absorption. Due to the fact that circulating levels of corticosteroids are usually below the limit of detection following application, there are no human data regarding the pharmacokinetics of topical corticosteroids. In such cases pharmacodynamic end points, including both hypothalamic-pituitary-adrenal (HPA) axis testing and topical vasoconstriction, are used as surrogates in the assessments of systemic exposure and relative potency, respectively.

In studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression, use of CLOBEX™ (clobetasol propionate) Shampoo, 0.05%, resulted in demonstrable HPA axis suppression in 5 out of 12 (42%) adolescent patients (See PRECAUTIONS).

CLOBEX™ Shampoo is in the super-high range of potency in vasoconstrictor studies.


The safety and efficacy of CLOBEX™ (clobetasol propionate) Shampoo, 0.05%, has been evaluated in two clinical trials involving 290 patients with moderate to severe scalp psoriasis. In both trials, patients were treated with either CLOBEX™ Shampoo or the corresponding vehicle applied once daily for 15 minutes before lathering and rinsing for a period of 4 weeks. Efficacy results are presented in the table below.

Shampoo Vehicle
Study A Study B Study A Study B
Total Number of Patients 95 99 47 49
Success Rate 1 at Endpoint 2 40 (42.1%) 28 (28.3%) 1
Subjects with Scalp Psoriasis
Clear (None) at Endpoint Erythema 3
Scaling 3 17 (17.9%) 12 (12.1%) 3 1
Plaque Thickening 3 21 (22.1%) 15 (15.2%) (6.4%) (2.0%)
35 (36.8%) 34 (34.3%) 0 2
(0%) (4.1%)
5 5
(10.6%) (10.2%)
1 Success rate defined as the proportion of patients with a-0 (clear) or 1 (minimal) on a 0 to 5 point physician's Global Severity Scale for scalp psoriasis.
2 At four (4) weeks or last observation recorded for a subject during the treatment period (baseline if no post-baseline data were available).
3 Patients with 0 (clear) on a 0 to 3 point scalp psoriasis parameter scale.

Clinical studies of Clobetasol Propionate Shampoo, 0.05%, did not include sufficient numbers of non-Caucasian patients to determine whether they respond differently than Caucasian patients with regards to efficacy and safety.

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