1. Section Editor(s): Hess, Cathy Thomas BSN, RN, CWOCN

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Effects of topical anti-inflammatory agents on cutaneous wound healing

Investigators are enrolling healthy men and women between 60 and 80 years old in a clinical trial to evaluate the efficacy and safety of a topically applied protein, Secretory Leukocyte Protease Inhibitor (SLPI) peptide, as a treatment for impaired wound healing in the elderly. Those who meet the eligibility requirements and are enrolled in the trial will be randomly assigned to receive a gel form of SLPI or a placebo applied to 2 punch biopsies made to both upper inner arms. The 4 wounds will be left to heal and excised at either day 7 or day 50 post-wounding. The study is being sponsored by the National Institute of Dental and Craniofacial Research. For more information on the trial, visit the Web site and click on "Effects of Topical SLPI on Skin Wounds."


LEVAQUIN (levofloxacin) tablets/injection

The FDA has approved a new indication for LEVAQUIN tablets/injection (levofloxacin tablets/injection): treatment of complicated skin and skin structure infections caused by methicillin-sensitive Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis. Complicated skin and skin structure infections include deep wounds, surgical incisions, bites and lacerations that have become infected, major abscesses, and infected ulcers. The dosage is 750 mg once daily. LEVAQUIN is also used in lower dosages of 500 mg and 250 mg to treat respiratory, urinary, and other types of skin infections. The higher dosage is needed for patients with underlying conditions, such as poor circulation and compromised immune systems.


The results of a recently completed Phase III trial demonstrate the safety and efficacy of levofloxacin 750 mg once daily for the treatment of complicated skin infections. Among 270 clinically evaluable subjects, clinical success rates were 84.1% in the levofloxacin treatment group, compared with 80.3% in the comparator treatment group. The comparators in the clinical trials were injectable ticarcillin/clavulanate either alone or followed by oral amoxicillin/clavulanate.


Adverse events reported with the 750 mg dose of LEVAQUIN were consistent with the 500 mg profile. The incidence of drug-related adverse events in subjects during all Phase III clinical trials conducted in the United States and Canada, in which levofloxacin 250 mg to 750 mg, depending on indication, was administered, was 6.3%. The most common adverse events related to levofloxacin use were nausea (1.3%) and diarrhea (1.0%).


BLU-U Blue Light Photodynamic Therapy Illuminator

The Food and Drug Administration (FDA) has granted Berlex Laboratories, Inc, Montville, NJ, and DUSA Pharmaceuticals, Inc, Wilmington, DE, approval of the commercial BLU-U Blue Light Photodynamic Therapy Illuminator, used exclusively in the LEVULAN Photodynamic Therapy (PDT) System for treatment of nonhyperkeratotic actinic keratoses (AKs) of the face or scalp. The LEVULAN PDT System is the first to topically deliver the active ingredient, aminolevulinic acid (ALA); the solution is applied directly to the lesion, followed by exposure to the BLU-U.


In clinical trials, 1 treatment with the LEVULAN PDT System achieved complete clearing of all AK lesions in more than 70% of patients at 12 weeks. A second treatment, if necessary, was done at 8 weeks. With 1 or 2 treatments, 88% of patients had 75% or more of their AK lesions cleared. Ninety-four percent of patients rated the way their appearance responded to treatment as excellent or good. Transient local symptoms of stinging and/or burning, itching, erythema, and edema may occur during treatment with the LEVULAN PDT System. However, during clinical trials, fewer than 3% of patients discontinued light treatment due to stinging and/or burning.