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Topica Pharmaceuticals reported results from a phase I/IIa trial of luliconazole for the treatment of onychomycosis of the toenails. The open label trial enrolled 24 subjects with moderate to severe distal subungual onychomycosis of the toenails. The subjects received once-daily applications of a 10% luliconazole solution for 28 days. All subjects completed the trial at the starting dose, and the 10% luliconazole solution was well tolerated. Steady state levels of luliconazole were reached in the plasma by day eight due to the time required for the drug to cross the nail plate and nail bed before reaching the circulation. The plasma levels of luliconazole were low, implying little risk for safety concerns or drug-drug interactions.
Celtic Pharma issued positive results from a phase II trial of TDT-067 for the treatment of onychomycosis. This open label was designed to evaluate the safety and efficacy of the topically applied treatment over 12 weeks. The primary endpoint was mycological cure at 14 weeks and follow up to 48 weeks. A 90% negative mycological cure rate (as defined by negative culture) was observed at 14 weeks; at 48 weeks the mycological cure rate was 38% despite no active treatment for the preceding 36 weeks. TDT-067 was well tolerated with little systemic drug exposure.
Barrier Therapeutics announced positive preliminary results from a phase IIa trial of pramiconazole for the treatment of onychomycosis of the toenails. This open label single-arm study enrolled 18 subjects who were treated with 200 mg of pramiconazole once weekly for 12 weeks. The subjects were subsequently followed for an additional 36 weeks after the initial treatment period. Results at week 16 revealed a marked clinical improvement in total signs and symptoms of onychomycosis, as measured by nail plate thickening, discoloration and overall appearance of the affected toenail, compared to baseline (p=0.001). In addition, at three months post-treatment, 31% of the subjects demonstrated both mycological cure and a significant decrease in clinical signs and symptoms of the affected toenail. This is an ongoing trial.
Anacor reported interim results of a phase II trial of AN2690, for the treatment onychomycosis (fungal infection of the nail and nail bed), at the Perspectives in Percutaneous Penetration 10th International Conference in La Grande Motte, France. Trial data yielded preliminary evidence of efficacy at the study's halfway point: mean clear nail growth was at 52% of the goal (2.6 mm of a target growth of 5 mm), the trial's primary endpoint. Further, 100% of fungal culture samples were consistently negative starting at day 30, and visible improvement in the nail plate was observed. This open-label study enrolled 60 patients, who were to receive one of two doses of the drug (5% or 7.5% solution) topically to the affected area daily for 180 days.