A Randomized Exploratory Study to Investigate the Inflammatory Response During an Ultraviolet-Radiation-Induced Cold Sore Episode.

INTRODUCTION: Antivirals and occlusive lip patches are key treatments for cold sores. Additional therapeutic options, and validated methods to evaluate these, are needed. METHODS: This exploratory, double-blind, single-center study aimed to evaluate a novel lip patch containing the antiviral aciclovir (ACV) using noninvasive methods for measuring cold sore-associated inflammation. Healthy subjects with ultraviolet radiation (UVR)-induced cold sores were randomized to 10 days' treatment with a lip patch containing ACV (N = 12) or without ACV (N = 13). Outcome measures included blood flux (field laser perfusion imaging, FLPI), skin temperature (thermography), and skin redness (high-resolution color photography, HRCP). RESULTS: Mean blood flux (in perfusion units) and skin temperature (in °C/pixel) were higher for cold sores versus intrasubject control regions. For ACV versus placebo patches, skin temperature was higher for ACV with total day 1-5 mean values of 2.6 versus 0.5 (p = 0.036) and day 1-10 mean values of 3.2 versus 0.8 (p = 0.049). Conversely, mean total episode blood flux values over days 1-5 were lower for ACV versus placebo patch (flux 2227 versus 2939, p = 0.340) and remained lower over days 1-10 (flux ACV 810 versus placebo 961, p = 0.404). HRCP failed to discriminate cold sores from control regions or between treatments. Subject-reported pain/soreness, itching, and burning were generally lower with ACV patch. CONCLUSIONS: FLPI reliably measures cold sore-related inflammation and thermography heat radiating from the skin. HRCP was of little value. TRIAL REGISTRATION: NCT01653509.

Human Exposures to N,N-diethyl-m-toluamide insect repellents reported to the American Association of Poison Control Centers 1993-1997.

This study analyzed 20,764 exposures involving insect repellants containing N,N-diethyl-m-toluamide (DEET) that were reported to poison control centers from 1993 to 1997. Nearly 70% of the cases reported no symptoms related to the exposure. The occurrence of symptoms was related to the route of exposure, with the highest rates associated with ocular exposures, followed by inhalation, multiple exposure routes, dermal, and ingestion. Two deaths were reported, one in a 26-year-old male and one in a 34-year-old female, both following a dermal exposure. Twenty-six subjects experienced major effects. The greatest number of reported exposures involved infants and children, but this group experienced lower rates of adverse effects than teens or adults. There was no clear relationship between DEET concentration and presence or severity of clinical effects. For the cases reported to poison control centers and included in this analysis, the risk of serious medical effects for labeled use of insect repellants containing N,N-diethyl-m-toluamide appears to be low.

Using community pharmacies to conduct an HSV-1 prevalence study.

PURPOSE: To describe the effectiveness of community-based pharmacists in conducting a study to measure the baseline prevalence of Herpes simplex virus, type-1 susceptibility to two antiviral medications in subjects with recurrent Herpes labialis. METHOD: A cross-sectional study conducted in 47 US community pharmacies. The pharmacist obtained a viral sample from the surface of the lesion, placed the virus-laden swab in a vial of holding medium, and stored it in a refrigerator until shipment to a central laboratory. RESULTS: The population that had swabs processed for viral isolation (1795) was predominantly white (90.1%) and female (67.9%) with a mean age of 37.5 years. A total of 1087 (60.3%) swabs were positive for HSV-1. On-site monitoring revealed 219 protocol deviations related to the stage of the lesion (124), not properly dating or signing the consent form (80), and indeterminate age (15). CONCLUSIONS: This study demonstrates the ability of pharmacists to conduct a large surveillance study in busy community pharmacies. A population of RHL sufferers with active lesions was recruited to study pharmacies during a 5-month period. Pharmacists successfully obtained viral samples from cold sore lesions at a rate comparable to physician-conducted studies. Protocol deviations were generally not serious, and did not compromise the study results or endanger the rights or welfare of participants.