CLOBEX

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. Inflammation and other disease processes in the skin may increase percutaneous absorption. There are no human data regarding the distribution of corticosteroids to body organs following topical application. Nevertheless, once absorbed through the skin, topical c...

The efficacy of CLOBEX Lotion, 0.05% in psoriasis and atopic dermatitis has been demonstrated in two adequate and well-controlled clinical trials. The first trial was conducted in subjects with moderate to severe plaque psoriasis. Subjects were treated twice daily for 4 weeks with either CLOBEX Lotion, 0.05% or vehicle lotion. Trial results demonstrated that the efficacy of CLOBEX Lotion, 0.05% in treating moderate to severe plaque psoriasis was superior to that of vehicle. At the end of treatment (4 weeks), 30 of 82 subjects (36.6%) treated with CLOBEX Lotion, 0.05% compared with 0 of 29 (0%)...

The most common adverse reactions (incidence > 1%) are skin atrophy, telangiectasia, discomfort skin and skin dry. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of anot...

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Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis at the lowest doses tested. ( 5.1 ) Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. ( 5.1 ) Systemic absorption may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. (5.1) Children may be more susceptible to sys...