Category Archives: Dermatology

Explosive Data: Fireworks Injuries Skyrocket on July 4th

It’s as predictable as taxes in April. Every year, the Fourth of July brings patriotic displays of color, smoke, and sound — and a slew of emergency room visits from burns and blast wounds.

Federal researchers track data on those injuries year-round using the National Electronic Injury Surveillance System, a national probability sample of about 100 hospitals in the U.S. and its territories. Fireworks injuries don’t only happen in July, but they are, unsurprisingly, far more common in that month versus the rest of the year.

Even when fireworks are sold legally, they are still prone to safety recalls. 36,100 units of TNT Red, White & Blue smoke fireworks were recalled because the fireworks may explode unexpectedly.

Fireworks law varies widely
Where fireworks laws do exist, they vary wildly from state to state, or even from county to county. In Massachusetts and New Jersey, it’s illegal to buy or sell fireworks at all. In Ohio, fireworks are available for purchase, but consumers have to sign a document stating they’ll take them out of the state within 48 hours. And in spite of known hazards here’s a surprising fun fact: Four states (Arkansas, Mississippi, North Dakota, and Oklahoma) allow residents to legally purchase fireworks at age 12.

So who gets hurt?
Legal fireworks or not, children are much more likely than adults to get hurt — 12-year-olds sustain more fireworks injuries than any other age group. But age isn’t the only factor playing into fireworks injuries: Men are more likely to be hurt than women.  So what about trends in the data? If you look at injury rates over the last two decades, you see that injuries to teenagers and children have dropped since 2005, but injuries among 20-40-year-olds are creeping up.  And what goes wrong most often? The most common type of injury is thermal burns. Sparklers are an unassuming culprit in the hands of any child.

The injuries span a wide range — from a 2-year-old boy who sustained a burn to his eye after his brother accidentally hit him with a sparkler to a 23-year-old who had a bottle rocket explode in his hands and needed a finger amputated.  Some of the data points are indirect injuries: One patient suffered bites after fireworks spooked a nearby dog. And a 10-year-old girl put two pieces of bathroom tissue in her ear to drown out the noise of fireworks.

See a full set of data graphs for this article at: STAT NEWS

Source: By Natalia Bronshtein, Displayed with permission courtesy of STAT News via Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

Adding Friendly Bacteria to Skin Lotion Wards Off Bad Germs

Customized creams guarded five patients with a kind of itchy eczema against risky bacteria that were gathering on their cracked skin.

Bacteria live on everyone’s skin, and new research shows some friendly germs produce natural antibiotics that ward off their disease-causing cousins. Now scientists are mixing the good bugs into lotions in hopes of spreading protection. In one early test, those customized creams guarded five patients with a kind of itchy eczema against risky bacteria that were gathering on their cracked skin, researchers reported.

Image courtesy of Shutterstock

“It’s boosting the body’s overall immune defenses,” said Dr. Richard Gallo, dermatology chairman at the University of California, San Diego, who is leading the work.

We share our bodies with trillions of microbes that live on our skin, in our noses, in the gut. This community  – what scientists call the microbiome  – plays critical roles in whether we stay healthy or become more vulnerable to various diseases. Learning what makes a healthy microbiome is a huge field of research, and already scientists are altering gut bacteria to fight diarrhea-causing infections.  The research sheds new light on the skin’s microbiome, suggesting that one day it may be possible to restore the right balance of good bugs to treat skin disorders, too.

Healthy skin harbors a different mix of bacteria than skin damaged by disorders such as atopic dermatitis, the most common form of eczema. Those patches of dry, red, itchy skin are at increased risk of infections, particularly from a worrisome germ known as Staphylococcus aureus.

Gallo’s team took a closer look at how microbes in healthy skin might be keeping that bad staph in check.  They discovered certain strains of some protective bacteria secrete two “antimicrobial peptides,” a type of natural antibiotic. In lab tests and on the surface of animal skin, those substances could selectively kill Staph aureus, and even a drug-resistant strain known as MRSA, without killing neighboring bacteria like regular antibiotics do, the team reported in the journal Science Translational Medicine.

But those good bugs are rare in the skin of people with atopic dermatitis, Gallo said.  “People with this type of eczema, for some reason that’s not quite known yet, have a lot of bacteria on the skin but it’s the wrong type of bacteria. They’re not producing the antimicrobials they need,” he explained. Would replenishing the good bugs help? “They’re normal skin bacteria, so we knew they would be safe,” Gallo noted.

His team tested five volunteers with atopic dermatitis who had Staph aureus growing on their skin’s surface  – what’s called colonization, but didn’t have an infection. Researchers culled some of the rare protective bacteria from the volunteers’ skin, grew a larger supply and mixed a dose into an over-the-counter moisturizer. Volunteers had the doctored lotion slathered onto one arm and regular moisturizer on the other.

A day later, much of the staph on the treated arms was killed – and in two cases, it was wiped out, compared to the untreated arms, Gallo said.  “We’re encouraged that we see the Staph aureus, which we know makes the disease worse, go away,” he said.

The study couldn’t address the bigger question of whether exposure to the right mix of protective bacteria might improve atopic dermatitis itself, cautioned Mount Sinai’s Guttman-Yassky. Next-step clinical trials are underway to start testing effects of longer-term use.

Source: By Lauran Neergaard, AP, Displayed with permission from STAT via RePubHub

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

A Novel Drug for Treatment of Necrotizing Soft-Tissue Infections

Criterium, Inc., a full-service CRO is proud to be the CRO of record as the supplier of services and support for this important trial.  Further study details are provided by the pharmaceutical development sponsor, AtoxBio Ltd. on ClinicalTrials.gov

Clincial Trial Results ReportA complete article detailing the trial and its current progress was highlighted in JAMA’s April 2014 issue in print and online (http://archsurg.jamanetwork.com/article.aspx?articleid=1859986).  This is a study to evaluate the safety and pharmacokinetics profile of different doses of AB-103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care. The primary study hypothesis is that AB-103 can be administered safely to the patients presenting with Necrotizing Soft Tissue Infections. Secondary endpoints are efficacy by exploratory descriptive analyses of specific efficacy endpoints from three outcome domains to demonstrate treatment benefit of AB-103 in comparison to placebo in patients with Necrotizing Soft Tissue Infections.

The efficacy domains Lab-Beakersare:

  1. Clinical status domain
  2. Pharmacoeconomics domain
  3. Systemic and local inflammatory biomarker domain

Criterium, with extensive experience in dermatology and infectious disease indications, particularly with wound and burn treatments, provided services for data and project management, clinical and medical monitoring, biostatistics, safety, regulatory support, and medical writing.

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Clinical Trials Monthly Case Study Analysis

SEPTEMBER Monthly Case Study Analysis:

Analyzing trial management through a different microscopeEach month, we look at a different Clinical Trial Case Study – this month it’s a look inside a Phase II Dose Ranging Dermatology trial that focused on Regulatory Environment issues.

The Scenario: A Phase II NDA trial with 4 expert sites, in 4 countries enrolled 80 patients, in less than four months with outstanding clinical results.

We asked ourselves: What if the deadline for this product became critical? In principal, they needed to finish the study for their development partner before they completed the preclinical safety dossier.

The client decided to conduct this study outside of the US so they would not need to submit the study to the IND.  Our international field, data accession, and consultant team selected and managed 1 site each in Ecuador, New Zealand, South Africa and Sweden. The team enrolled the required number of patients in just 16 weeks. The data were transmitted in real time to Saratoga Springs, NY, where the database was closed within two weeks. This information was provided to our statistical group, which completed the analysis and final CSR (clinical study report) ahead of schedule.

Our Answer: Criterium saved more than three months and met the client’s deadline for corporate evaluation of the product.

Preparing clinical trials from financial issues upfront is always the ideal, but extension dates and changing timelines are variables that have to be accounted for in planning.  When we look at trial bids, we look at all the factors that surround the potential issues facing a trial – location & timing can be tools to keep trials running smooth, not just challenges to overcome.

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersWed, 19 Sep 2012 20:51:00 GMTf1397696-738c-4295-afcd-943feb885714:222699