Therapeutics Focus: Fungal Infections

Study Evaluates Efficacy and Safety of 1064-nm Nd:YAG Laser in Treatment of Onychomycosis

A recent study was conducted to evaluate the efficacy and side effects of onychomycosis treatment with a long-pulsed 1064-nm Nd:YAG laser. Sixty-four onychomycotic nails (35 patients) were evaluated. Involved nails were treated with a long-pulsed 1064-nm Nd:YAG laser in four sessions at one-week intervals. A potassium hydroxide examination and fungal culture were performed every week during the treatment course and at a one-month follow-up visit. If either test was positive for a pathogenic organism, a second treatment cycle was performed. If the two tests produced negative results, each affected nail was followed up at three- and six-month visits after completion of the second treatment protocol. In cases of resistance (positive for a pathogenic organism after completion of the second treatment cycle), the onychomycotic nails were excluded from the study and treated by standard methods. Of 64 nails evaluated, 59 completed the first cycle of treatment and 24 (40.7 percent) demonstrated mycological clearance at the one-month follow up. Thirty-five of the 59 nails (59.3 percent) were positive for a pathogenic organism and underwent a second treatment cycle. Upon completion of the second cycle, 28 nails remained enrolled, and the mycological test results were negative in nine nails (31.2 percent). For all nails that completed the first or second treatment cycle, the overall cure rates at the one-, three- and six-month follow-up visits were 63.5 percent, 57.7 percent and 51.9 percent, respectively. Side effects were mild and limited to erythema and swelling after the laser procedure. The researchers concluded that long-pulsed 1064-nm Nd:YAG laser therapy is safe and effective for the treatment of onychomycosis, but acknowledged that a larger sample size and longer follow-up period are needed to confirm these findings.

—J Dermatolog Treat. 2015 Apr 17:1-5.

Evaluating Efinaconazole in Patients with Onychomycosis and Coexisting Tinea Pedis

To evaluate the efficacy of efinaconazole topical solution 10% in patients with onychomycosis and coexisting tinea pedis, researchers analyzed 1,655 patients, aged 18 to 70 years, randomized (3:1) to receive efinaconazole topical solution 10% or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (zero percent clinical involvement of the target toenail and negative potassium hydroxide examination and fungal culture findings) at week 52. Three groups were compared: patients with onychomycosis and coexisting interdigital tinea pedis on-study (treated or left untreated) and those with no coexisting tinea pedis. The study found that treatment with efinaconazole topical solution 10% was significantly more effective than vehicle use irrespective of the coexistence of tinea pedis or its treatment. Overall, 21.3 percent of patients with onychomycosis had coexisting interdigital tinea pedis at baseline, with 61.1 percent of these patients receiving investigator-approved topical antifungal agents for their tinea pedis in addition to their randomized onychomycosis treatment. At week 52, efinaconazole complete cure rates of 29.4 percent were reported in patients with onychomycosis when coexisting tinea pedis was treated compared with 16.1 percent when coexisting tinea pedis was not treated. Both cure rates were significant compared with vehicle, and in the latter subgroup, no patients treated with vehicle achieved a complete cure.

The study authors concluded, “Treatment of coexisting tinea pedis in patients with onychomycosis enhances the efficacy of once-daily topical treatment with efinaconazole topical solution, 10%.”

—J Am Podiatr Med Assoc. 2015 Apr 13.

Clinical Trial Evaluates Squalamine Ointment for Tinea Capitis Treatment

A Phase II randomized, double-blind, placebo-controlled clinical trial was conducted to test the efficacy and safety of a three-week squalamine ointment regimen for the treatment of tinea capitis. Males aged six to 15 years presenting with tinea capitis were treated with either topical squalamine ointment or placebo for three weeks. The primary endpoint was complete clinical cure. The secondary endpoints were the occurrence of local and/or systemic adverse events, mycological cure, and partial clinical response. Prospective follow-up of clinical adverse events was performed daily. Five patients were treated with 1% squalamine ointment and 15 were treated with placebo. No complete cure was observed. No clinical or biological adverse event was recorded. A significantly better hair-growth score, indicating a partial clinical improvement of the tinea capitis, was observed in the patients treated with squalamine compared to those treated with placebo. The researchers found that this three-week squalamine ointment regimen was well tolerated and showed partial clinical activity for the treatment of tinea capitis. They noted that further studies are needed to evaluate the efficacy of topical squalamine alone or in combination with an antidermatophyte drug to treat tinea capitis. n

—Mycopathologia. 2015 Apr;179(3-4):187-93.