Derma-Smoothe Scalp/FS

Derma-Smoothe Scalp/FS

CLINICAL PHARMACOLOGY

Like other topical corticosteroids, fluocinolone acetonide 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 and the integrity of the epidermal barrier. Occlusion of topical corticosteroids can enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Also, inflammation and/or other disease processes in the skin can increase percutaneous absorption.

Derma-Smoothe/FS® is in the low to medium range of potency as compared with other topical corticosteroids.

Clinical Studies

In a vehicle-controlled study for the treatment of psoriasis of the scalp in adults, after 21 days of treatment, 60% of patients on active treatment and 21% of patients on the drug vehicle had excellent to cleared clinical response.

Open-label safety studies on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis, and baseline body surface area involvement greater than 75% in 18 patients, and 50% to 75% in 15 patients, were treated with Derma-Smoothe/FS® twice daily for 4 weeks. Morning pre-stimulation cortisol level and post-Cortrosyn stimulation cortisol level were obtained in each subject at the beginning of the trial and at atment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 ug/dL; normal: cortisol > 7 ug/dL) but all had normal responses to 0.25 mg of Cortrosyn stimulation (cortisol > 18 ug/dL).

A clinical study was conducted to assess the safety of Derma-Smoothe/FS®, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 patients with atopic dermatitis, 6 to 17 years of age. Of the 13 patients, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the responses to both prick test and patch test utilizing refined peanut oil NF, Derma-Smoothe/FS® and histamine/saline controls, on the 13 individuals. These subjects were also treated with Derma-Smoothe/FS® twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to Derma-Smoothe/FS® and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of Derma-Smoothe/FS® use. Importantly, the bulk peanut oil NF, used in Derma-Smoothe/FS® is heated at 475° F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.

Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.

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Derma-Smoothe Scalp/FS - User Reviews

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