Ciclopirox 8% nail lacquer topical solution for the treatment of onychomycosis in patients with diabetes: a multicenter, open-label study.

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.

• Authors: Marc A Brenner, Lawrence B Harkless, Robert W Mendicino, Jeffrey C Page
• Journal: Journal of the American Podiatric Medical Association (J Am Podiatr Med Assoc) 2007 May-Jun Vol. 97 Issue 3 Pg. 195-202 ISSN: 8750-7315 [Print] United States
• PMID: 17507527 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antifungal Agents
• Pyridones
• Ciclopirox

Topics

• Administration, Cutaneous
• Adult
• Aged
• Aged, 80 and over
• Antifungal Agents (administration & dosage, therapeutic use)
• Ciclopirox
• Diabetes Mellitus, Type 2 (complications)
• Female
• Foot Dermatoses (complications, drug therapy)
• Humans
• Lacquer
• Male
• Middle Aged
• Onychomycosis (complications, drug therapy)
• Pyridones (administration & dosage, therapeutic use)
• Treatment Outcome