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.
Transdermal patches can be a very precise time released method of delivering a drug. Cutting a patch in half might affect the dose delivered. The release of the active component from a transdermal delivery system (patch) may be controlled by diffusion through the adhesive which covers the whole patch, by diffusion through a membrane which may only have adhesive on the patch rim or drug release may be controlled by release from a polymer matrix. Cutting a patch might cause rapid dehydration of the base of the medicine and affect the rate of diffusion.