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* Dermatitis.SkinMedica, Inc, Carlsbad, CA, reported the positive outcome of 2 phase III clinical trials evaluating desonide (Desonate HydroGel 0.05%), a low-potency topical steroid formulated in a proprietary alcohol-free, aqueous gel delivery vehicle to treat atopic dermatitis. The multicenter, randomized, double-blind, placebo-controlled comparison study involved 582 pediatric patients, aged 3 months to 18 years, with mild to moderate atopic dermatitis. Patients received either Desonate HydroGel or placebo twice daily for 4 weeks.


Results demonstrated a significant treatment effect for Desonate HydroGel in both primary and secondary end points. The product was well tolerated; the most frequently observed adverse effects were mild in nature and largely limited to application site reactions.




* Psoriasis.Connetics Corporation, Palo Alto, CA, announced that phase IV clinical study results evaluating the long-term efficacy of a lower dosage of acitretin (Soriatane) indicate that the low-dose regimens were effective and well tolerated over a 6-month period in the treatment of moderate to-severe plaque-type psoriasis in adults. A poster highlighting the results was presented at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco, CA.


The current Soriatane treatment practice is to administer the maximum tolerable dose, from 25 to 60 mg/day, while also managing the dose-related adverse effects, noted Jennifer Cather, MD, Modern Dermatology, Baylor University Medical Center, Dallas, TX. The daily low-dose regimen of 10 or 25 mg over a 6-month period has demonstrated to be as effective when compared with the current more aggressive treatment regimen. With these results, Connectics anticipates that patients could begin initial therapy with a low-dose 25-mg regimen of Soriatane and experience a positive response with fewer adverse effects.





* Peripheral artery disease. Individuals with diabetes and peripheral artery disease (PAD) are at a higher risk for cardiac death, according to a study published in the March 2006 issue of Diabetes Care. The Fremantle Diabetes Study (FDS) observed 1294 patients with type 2 diabetes. The researchers defined PAD as an ankle brachial index (ABI) of less than or equal to 0.90 at 2 consecutive evaluations or any PAD-related lower extremity amputation.


The findings indicated that PAD was significantly associated with smoking, and increases in age, systolic blood pressure, and total serum cholesterol. In addition, an ABI of no more than 0.90 was associated with 67% increased risk of cardiac death.


Source: Norman PE, Davis WA, Bruce DG, Davis TM. Peripheral areterial disease and risk of cardiac death in type 2 diabetes: the Fremantle Diabetes Study. Diabetes Care. 2006;29:575:80.


* Neuropathy.Sangamo BioScience, Inc, San Diego, CA, announced positive results from the phase I human clinical trial of SB-509, the company's ZFP Therapeutic (zinc finger DNA-binding protein transcription factor [ZFP TF]) for the treatment of diabetic neuropathy. The findings were presented at the 58th Annual Meeting of the American Academy of Neurology in San Diego.


SB-509 is designed to directly protect and restore nerve function by up regulating the expression of the gene encoding vascular endothelial growth factor in patients with diabetes who suffer from peripheral neuropathy. The study's main objective was to test clinical and laboratory safety. In the single-blind, single-treatment, dose-escalation trial, 12 patients with mild to moderate diabetic peripheral neuropathy received the agent by intramuscular injection in a distribution along the major peripheral nerves in the legs and feet. Improvements in pain, numbness, and neurologic symptoms were observed in about 50% of patients who received a single treatment of SB-509.