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


CONCLUSIONS
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.
Brenner
Marc A
MA
Institute for Diabetic Foot Research, Glendale, NY 11385, USA.
Harkless
Lawrence B
LB
Mendicino
Robert W
RW
Page
Jeffrey C
JC
D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000008:administration & dosage / Q000627:therapeutic use; D000077768:Ciclopirox; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D005260:Female; D005533:Foot Dermatoses / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007764:Lacquer; D008297:Male; D008875:Middle Aged; D014009:Onychomycosis / Q000150:complications / Q000188:drug therapy*; D011728:Pyridones / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D000935:Antifungal Agents; D011728:Pyridones; D000077768:Ciclopirox