Can Light Make Your Toenails Look Better? Keraderm Has Clinical Trials Underway To Find Out

Main Category: Dermatology
Also Included In: Clinical Trials / Drug Trials
Article Date: 10 Sep 2008 - 3:00 PDT

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Is it possible to use the healing power of light to treat infections? Keraderm, a leader in the development of light-based treatments for infections, thinks so. Keraderm announced full enrollment for pivotal trials to obtain FDA clearance of its phototherapy treatment for onychomycosis (fungal nail infections). The objectives of the pivotal trials are to confirm the efficacy and safety of Keraderm's treatment for patients with onychomycosis.

Eighty-five subjects with confirmed onychomycosis have been enrolled in the prospective, placebo controlled, double blind, multi-site trial. Study objectives include assessing safety, clinical improvement, mycological cure and visual improvement of the treated nail. Patients will receive four twenty- minute treatments over a four-week period and will be followed up to assess safety and efficacy of the treatments after several months.

Keraderm's germicidal light technology has been clinically shown to successfully inactivate the organisms that cause onychomycosis. The results of Keraderm's collaboration with the Wellman Center for Photomedicine, an affiliate of Harvard Medical School, on a grant from the National Institute of Health have recently been published in the prestigious peer-reviewed British Journal of Dermatology. The data indicate that Keraderm's treatment is effective at penetrating the nail and also inactivating the organisms that cause onychomycosis. Additionally, results of Keraderm's successful pilot clinical trials at Brigham and Women's Hospital, an affiliate of Harvard Medical School, have been presented at the 2007 World Congress of Dermatology Conference and the 2008 American Academy of Dermatology Conference. These pilot clinical trials indicated significant improvement in 73% of subjects treated with its proprietary technology with no significant side effects. Keraderm anticipates an increased improvement rate in the current pivotal trials due to further enhancements of its technology.

About Keraderm

Keraderm LLC is a medical device company with proprietary, patented, platform technology for a wide variety of skin and nail infections. This technology has the potential to effectively treat infections without the serious side effects that many medications have and to effectively treat infections caused by drug-resistant organisms such as MRSA. Keraderm has obtained patents on its key technologies to treat infections and has a number of additional patent applications pending on refinements of its technology. Published laboratory and clinical studies indicate that the technology has great potential to effectively and safely treat infections.

Forward-looking statements

Statements in this press release containing the words believe, may, expect, project and other similar expressions are forward-looking statements that are not definite and have a number of risks and uncertainties. Representative factors that can cause actual results to differ from those projected include the following: regulatory clearance of products, market acceptance; financial constraints; government regulations; obtaining and enforcing intellectual property rights; attracting and retaining key employees; developing partnership opportunities; timing of commercial product launches; and other similar internal and external risks factors.

Keraderm LLC
http://www.keraderm.com