The safety and efficacy of once daily use of JUBLIA for the treatment of onychomycosis of the toenail were assessed in two 52-week prospective , multi-center, randomized, double-blind clinical trials in patients 18 years and older (18 to 70 years of age) with 20% to 50% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix) involvement. The trials compared 48 weeks of treatment with JUBLIA to the vehicle solution. The Complete Cure rate was assessed at Week 52 (4 weeks after completion of therapy). Complete cure was defined as 0% involvement of the target toenail (no clinical evidence of onychomycosis of the target toenail) in addition to Mycologic Cure, defined as both negative fungal culture and negative KOH. Table 2 lists the efficacy results for trials 1 and 2.
Phototherapy (light therapy) : Ultraviolet (UVL) light, a portion of the solar spectrum with wavelengths between 290-400 nm, can have beneficial effects on psoriatic skin presumably by altering certain immune functions. Disease that is considered too extensive to be treated by topical approaches, that is usually greater than 5%-10% of the total body surface area, is an appropriate indication for this sort of treatment. Resistance to conventional topical treatment is another indication for light therapy. Although normal sunlight contains these wavelengths, self-exposure to sunlight must be done in under controlled conditions to minimize burns. In a physician's office, control of the amount of light energy administered to each patient is essential. Medical light sources use special wavelengths of light and timers to assure the correct dosage of light. Sunlamps and tanning booths are not acceptable substitutes for medical light sources. Ultraviolet light from any source is known to produce skin cancer , but this side effect is minimized when the light is appropriately administered in a physician's office.