Recommended Topic Related To:

Desonate

"Aug. 5, 2013 -- Anyone who develops a rash, blister, or some other skin reaction while taking acetaminophen should stop using the drug and seek medical care immediately. The painkiller poses the risk for three rare but potentially fatal skin diso"...

Desonate

Desonate

CLINICAL PHARMACOLOGY

Mechanism of Action

The mechanism of action of desonide is unknown.

Pharmacodynamics

In an HPA axis suppression study, one of 37 (3%) pediatric subjects, 6 months to 6 years old, with moderate to severe atopic dermatitis covering at least 35% body surface area who applied Desonate (desonide gel) experienced suppression of the adrenal glands following 4 weeks of therapy [see WARNINGS AND PRECAUTIONS and Use In Specific Populations]. A follow-up evaluation of the subject's adrenal axis was not performed; it is unknown whether the suppression was reversible.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolized primarily in the liver and then are excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

Clinical Studies

In two randomized vehicle-controlled clinical studies, subjects 3 months to 18 years of age with mild to moderate atopic dermatitis were treated twice daily for 4 weeks with either Desonate (desonide gel) or vehicle. Treatment success was defined as achieving clear or almost clear on the Investigator's Global Severity Score (IGSS) with at least a 2-point change (decrease) from the subject's baseline IGSS when compared to the Week 4 IGSS. The results of the 2 clinical trials are summarized in Table 1:

Table 1: Subjects Achieving Treatment Success

Clinical Desonate
N = 289
Trial 1 Vehicle
N = 92
128 (44%) 13 (14%)
Clinical Trial 2
Desonate
N = 136
Vehicle
N = 65
38 (28%) 4 (6%)

Last reviewed on RxList: 1/28/2010
This monograph has been modified to include the generic and brand name in many instances.

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