Randomized Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy with Short-Pulsed 1,064-nm Neodymium-Doped Yttrium Aluminium Garnet Laser and Amorolfine Nail Lacquer for Onychomycosis.

BACKGROUND: Onychomycosis is one of the most prevalent fungal diseases in the general population. However, treatment is of limited effectiveness and must be administered for long periods of time. Systemic antifungal agents are associated with adverse effects. OBJECTIVE: We evaluated the clinical efficacy and safety of a 1,064-nm neodymium-doped yttrium aluminium garnet (Nd:YAG) laser with amorolfine nail lacquer to treat onychomycosis. METHODS: The 128 patients were randomly divided to 2 groups: 64 in the experimental group were treated with 1,064-nm Nd:YAG laser therapy and amorolfine nail lacquer; the other 64 were in a control group treated with topical amorolfine lacquer monotherapy. The laser treatment was 4 sessions at 4-week intervals and amorolfine lacquer was applied once a week for 16 weeks. Efficacy was assessed as response rate from standardized photographs with ImagePro®Plus (Media Cybernetics, Inc., USA) analysis, microscopic examination, and subjective evaluation. RESULTS: At 16 weeks, the experimental group showed a significantly higher cumulative cure rate than the control group (71.88% vs. 20.31%, p<0.0001). Clinical therapeutic effects were linked to patient satisfaction. The percent of "very satisfied" or "satisfied" responses was higher in the test group than the control group (81.25% vs. 23.44%). The treatment regimen was well tolerated, with transient discomfort observed in the test group. CONCLUSION: The 1,064-nm Nd:YAG laser with amorolfine nail lacquer was effective and safe for treating onychomycosis. This therapy should be considered an alternative treatment, especially for patients with contraindications to systemic antifungal agents.

Randomized Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy with Short-Pulsed 1,064-nm Neodymium-Doped Yttrium Aluminium Garnet Laser and Amorolfine Nail Lacquer for Onychomycosis

BACKGROUND: Onychomycosis is one of the most prevalent fungal diseases in the general population. However, treatment is of limited effectiveness and must be administered for long periods of time. Systemic antifungal agents are associated with adverse effects. OBJECTIVE: We evaluated the clinical efficacy and safety of a 1,064-nm neodymium-doped yttrium aluminium garnet (Nd:YAG) laser with amorolfine nail lacquer to treat onychomycosis. METHODS: The 128 patients were randomly divided to 2 groups: 64 in the experimental group were treated with 1,064-nm Nd:YAG laser therapy and amorolfine nail lacquer; the other 64 were in a control group treated with topical amorolfine lacquer monotherapy. The laser treatment was 4 sessions at 4-week intervals and amorolfine lacquer was applied once a week for 16 weeks. Efficacy was assessed as response rate from standardized photographs with ImagePro®Plus (Media Cybernetics, Inc., USA) analysis, microscopic examination, and subjective evaluation. RESULTS: At 16 weeks, the experimental group showed a significantly higher cumulative cure rate than the control group (71.88% vs. 20.31%, p<0.0001). Clinical therapeutic effects were linked to patient satisfaction. The percent of “very satisfied” or “satisfied” responses was higher in the test group than the control group (81.25% vs. 23.44%). The treatment regimen was well tolerated, with transient discomfort observed in the test group. CONCLUSION: The 1,064-nm Nd:YAG laser with amorolfine nail lacquer was effective and safe for treating onychomycosis. This therapy should be considered an alternative treatment, especially for patients with contraindications to systemic antifungal agents.

Anti-inflammatory activity of lanoconazole, a topical antifungal agent.

Topical antifungal agents which have anti-inflammatory effects have the potential to provide additional clinical benefits. Therefore, an anti-inflammatory activity of lanoconazole (LCZ), a topical antifungal agent, was investigated against in vitro and in vivo models of inflammation. The release of interleukin-8 (IL-8) from human epidermal keratinocytes stimulated by the addition of 100 µg ml(-1) ß-glucan of Saccharomyces cerevisiae was significantly inhibited by LCZ at the concentration of 10(-5) mol l(-1). The release of interferon-γ and IL-2 from human peripheral blood mononuclear cells stimulated by the addition of 30 and 100 µg ml(-1) phytohemagglutinin was significantly inhibited by LCZ at the concentrations of 10(-7) and 10(-6) mol l(-1), respectively. The increase in the ear thickness induced by topical application of 0.01% 12-O-tetradecanoyl phorbol-13-acetate and 1% 2,4,6-trinitrochlorobenzene (TNCB) after sensitisation with 3% TNCB were established as the mouse models of irritant and contact dermatitis, respectively. Application of 1% and 3% LCZ showed a significant anti-inflammatory activity against both the irritant and contact dermatitis models. These findings suggest that LCZ possesses an anti-inflammatory activity, which may be partially helpful in the treatment of dermatomycoses.