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Ciclopirox 8% Nail Lacquer Topical Solution for the Treatment of Onychomycosis in Patients with Diabetes

A Multicenter, Open-Label Study

Marc A. Brenner, DPM ^*, Lawrence B. Harkless, DPM , Robert W. Mendicino, DPM  and Jeffrey C. Page, DPM 

^* Institute for Diabetic Foot Research, Glendale, NY; Department of Podiatry, North Shore University Hospital, North Shore–Long Island Jewish Health System, Manhasset, NY.
Department of Orthopedics/Podiatry, University of Texas Health Science Center, San Antonio.
Division of Foot and Ankle Surgery, The Western Pennsylvania Hospital, Pittsburgh, PA.
Arizona Podiatric Medicine Program, Midwestern University–Glendale, Glendale, AZ.

Corresponding author: Marc A. Brenner, DPM, Institute for Diabetic Foot Research, 73-09 Myrtle Ave, Glendale, NY 11385.

Abstract

Background: An open-label, noncomparative study was conducted to assess the safety and efficacy of ciclopirox 8% nail lacquer topical solution in patients with type 2 diabetes mellitus.

Methods: Forty-nine diabetic patients with distal subungual onychomycosis were treated once daily for 48 weeks with ciclopirox 8% nail lacquer, a topical nail solution approved for the treatment of patients with mild-to-moderate onychomycosis.

Results: Treatment resulted in clinical improvement in 63.4% of patients. Most patients (85.7%) had a mycologic outcome of improvement or cure, with 54.3% attaining mycologic cure. Consideration of mycologic and clinical outcomes generated a treatment outcome of improvement, success, or cure in 84.4% of patients. Moreover, patients experienced improvement in the diseased area of the nail (63.4%), nail surface (56.1%), nail color (48.8%), and nail thickness (65.9%). Ciclopirox 8% nail lacquer was safe, with treatment-related adverse events limited to infection in one patient, which resolved in 15 days; the patient completed the study. No treatment-related serious adverse events were observed.

Conclusion: Ciclopirox 8% nail lacquer is a safe and effective treatment for distal subungual onychomycosis in patients with type 2 diabetes mellitus receiving insulin or oral hypoglycemic therapy. (J Am Podiatr Med Assoc 97(3): 195–202, 2007)