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.
The rationale for the use of vitamin D derivatives in the treatment of psoriasis is based on the observation that patients with hypocalcemia often develop various forms of psoriasis, most notably the pustular form. In one case, a patient who had undergone thyroidectomy developed repeated flares of pustular psoriasis after decreases were made in her dosage of ergocalciferol (Vitamin D 2 ); each episode was related to severe hypocalcemia and resolved after her serum calcium levels normalized. 14 Another patient with osteoporosis experienced dramatic improvement in severe psoriasis after receiving an oral form of vitamin D. 15 This finding, along with the discovery that the bioactive form of 1,25-dihydroxycholecalciferol has been shown to inhibit keratinocyte proliferation and promote keratinocyte differentiation, 16 has led to the development of vitamin D analogs for the treatment of psoriasis.
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.