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 subjects were 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 patients experienced 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.
Because P. aeruginosa and S. aureus are common pathogens in otorrhea, they must be considered at the time of treatment selection. Currently, no narrow-spectrum agent is available for the coverage of these two microbes. For the treatment of acute diffuse otitis externa, polymyxin B-neomycin-hydrocortisone combinations and fluoroquinolones are equally effective, and neither treatment carries known risk. The twice-daily dosing schedule of topical fluoroquinolones may improve compliance. When selecting treatment for acute otitis media with perforation, topical fluoroquinolones represent a good first-line option, although not clearly better than traditional topical therapy. For chronic suppurative otitis media topical fluoroquinolones likely represent the best choice because treatment is long, and repeated therapy is common. 18
Necrotizing otitis externa is difficult to treat, and the mortality rate can be as high as 53 percent. This condition should be suspected when, despite adequate topical treatment, otalgia and headache are disproportionately more severe than the clinical signs or when granulation tissue is apparent at the bony cartilaginous junction. The diagnosis should be confirmed by a computed tomographic (CT) scan or magnetic resonance imaging (MRI). A combination of technetium scanning to detect osteoblastic activity and gallium 67 imaging to detect granulocytic activity can be used in questionable cases and is recommended by some 4 , 25 as a means of monitoring response to treatment. The erythrocyte sedimentation rate (ESR) can also be used to monitor therapeutic response. 25