Source: FDA, National Drug Code (US) Revision Year: 2020
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.
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.
DermOtic Oil is in the low to medium range of potency as compared with other topical corticosteroids.
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of DermOtic Oil. Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide, the active ingredient in DermOtic Oil. Some corticosteroids have been found to be genotoxic in various genotoxicity tests (i.e. the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation, the in vivo mouse bone marrow micronucleus assay, the Chinese hamster micronucleus test and the in vitro mouse lymphoma gene mutation assay).
Efficacy in a placebo-controlled study for the treatment of chronic eczematous external otitis on 154 patients (adults and children 2 years of age and older) treated with five drops per ear of DermOtic Oil twice daily, after 7 days of treatment, showed DermOtic Oil to be superior to placebo in clearing the signs and symptoms of eczematous external otitis.
Clinical safety studies were conducted on the same formulation of fluocinolone acetonide oil 0.01%, marketed as Derma-Smoothe/FS Topical Oil. 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 Topical Oil 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 the end of 4 weeks of treatment. At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6µg/dL; normal: cortisol >7µg/dL) but all had normal responses to 0.25 mg of Cortrosyn stimulation (cortisol >18µg/dL).
A clinical study was conducted to assess the safety of Derma-Smoothe/FS Topical Oil, 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 peanut oil NF, Derma-Smoothe/FS Topical Oil and histamine/saline controls on the 13 individuals. These s also treated with Derma-Smoothe/FS Topical Oil twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to Derma-Smoothe/FS Topical Oil and the refined peanut oil. One of the 9 peanut-sensitive erienced an exacerbation of atopic dermatitis after 5 days of Derma-Smoothe/FS Topical Oil use. Importantly, the bulk peanut oil NF, used in Derma-Smoothe/FS Topical Oil is heated at 475°F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.
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