CINCINNATI—Spring is officially here, and that means people will soon ditch their hot sneakers for open-toed sandals and polished toenails. But for those with difficult-to-treat toenail fungus, spring can be an embarrassing time of year.
University of Cincinnati dermatologists are conducting a trial to compare the effectiveness of a once-a-day oral tablet for alleviating fungal nail infections with the currently prescribed capsule formulation approved by the Food and Drug Administration.
Led locally by Debra Breneman, MD, and Pranav Sheth, MD, the researchers need about 40 volunteers with fungal toenail infections known as onychomycosis (on-EE-ko-my-KO-sis) to participate in the national study.
The condition is caused by common skin fungi that invade the actual nail or infect the skin under the nail. As the infection progresses, it can cause the nail to thicken, crack and become discolored. This can result in discomfort and pain when walking or standing for long periods. Left untreated, it can cause permanent nail damage and become difficult to cure.
“Fungi thrive in warm, moist places—like between the toes—and can be spread through both direct and indirect contact,” explains Sheth. “Once the infection gets into the nail, it acts as a reservoir of fungus that can then lead to recurrent infection of the skin (athlete’s foot) and spread to other nails.
“These infections may be prevented by keeping nails short to minimize injuries that are susceptible to infection and by not sharing nail clippers or walking barefoot in public places,” he adds.
Sponsored by Barrier Therapeutics, the phase-3, evaluator-blind trial will determine whether the investigational oral tablet form of the drug itraconazole (eye-truh-CON-uh-zole) can safely eliminate toenail fungus in patients with onychomycosis.
“In general, treatment of fungal nail infections with antifungal creams, lotions or gels has not provided patients with satisfactory results” says Sheth. “Effective toenail infection treatment often requires prescription oral medications.”
The American Academy of Dermatology estimates that 12 percent of Americans have fungal infections of the fingernails or toenails. The condition occurs most often in people over 40 and in those with a family history of fungal nail infections, or in people with already impaired immune systems.
Study participants will be randomized into three treatment groups and receive treatment daily for 12 weeks. Each group will receive a 200-milligram itraconazole tablet, two 100-milligram itraconazole capsules, or a placebo to be taken once a day.
Researchers will track patients for up to 60 weeks, monitoring any changes in toenail fungus through periodic examinations and other medical monitoring procedures.
Study participants will be compensated up to $480 for full participation in this study and receive all study-related medications and care at no charge.
Sheth and Breneman have no financial interest in Barrier Therapeutics.
For more information on trial eligibility, call Vivian Berger at (513) 475-7575.
More information on nail infections is available at www.netwellness.org, a collaborative health-information Web site staffed by Ohio physicians, nurses and allied health professionals.