Smith, Edgar B., Wiss, Karen, Hanifin, Jon M., Jordon, Robert E., Rapini, Ronald P., Lasser, Alan E., Kirschenbaum, M. Barry, Millikan, Larry E., Parish, Lawrence Charles, Rapaport, Marvin J., Roenigk, Henry, Jr., Zaias, Nardo, Dromgoole, Sydney H., Sefton, John, DeGryse, Ronald, and Killey, Frank P.
The antifungal agent naftifine has been approved in the United States for twice daily treatment of fungal infections of the foot, skin, and other areas of the body. Studies in Europe showed that naftifine may also be effective in a once-daily regimen. The effectiveness of naftifine 1 percent cream applied once or twice daily was compared with twice-daily applications of clotrimazole 1 percent cream. The study involved 155 men and 55 women with tinea pedis, or fungal infection of the foot. Within six weeks, treatment success was achieved in 81 percent of patients receiving twice- daily naftifine compared with 58 percent of patients treated with twice-daily clotrimazole who responded to treatment. Once- or twice-daily naftifine was more effective in resolving symptoms, such as redness, cracking, and itching, than twice-daily clotrimazole. There were no differences in the effects of the different doses of naftifine. Once- and twice-daily naftifine was more effective than twice-daily clotrimazole in treating the hyperkeratotic plantar-type of tinea pedis. Treatment-associated side effects included blisters or increased scaling with once-daily naftifine; skin inflammation with naftifine twice-daily; and flaring of blisters with clotrimazole twice-daily. The success of antifungal treatment applied to the skin depends on both the effectiveness of the drug and the ability of the patient to comply with a drug regimen. The results show that the once-daily application of the antifungal agent naftifine is more effective than twice-daily treatment with the antifungal agent clotrimazole. (Consumer Summary produced by Reliance Medical Information, Inc.)