Fluocinolone acetonide oil, 0.01% is in the low to medium range of potency as compared with other topical corticosteroids

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 Fluocinolone Acetonide Oil, 0.01% twice daily, after 7 days of treatment, showed Fluocinolone Acetonide Oil, 0.01% 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 Fluocinolone Acetonide 0.01% 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 Fluocinolone Acetonide 0.01% Topical Oil twice daily for 41 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 6.6¡g/dL; normal: cortisol > 7¡g/dL) but all had normal responses to 0.25 mg of Cortrosyn stimulation (cortisol > 18¡g/dL).

A clinical study was conducted to assess the safety of Fluocinolone Acetonide 0.01% 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, Fluocinolone Acetonide 0.01% Topical Oil and histamine/saline controls on the 13 individuals. These subjects were also treated with Fluocinolone Acetonide 0.01% Topical Oil twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to Fluocinolone Acetonide 0.01% Topical Oil and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of Fluocinolone Acetonide 0.01% Topical Oil use. Importantly, the bulk peanut oil NF, used in Fluocinolone Acetonide 0.01% Topical Oil is heated at 475° F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.