669. A Comparative Evaluation of Combination Therapy of Fluconazole 1% and Urea 40% Compared with Fluconazole 1% Alone in a Nail Lacquer for Treatment of Onychomycosis: Therapeutic Trial
Session: Abstracts: Mycology
Friday, October 22, 2010

Onychomycosis is a common disease affecting as much as 8% of the general population. The incidence of this infection is increasing word wide. Treatment of onychomycosis is challenging, complicated by low cure rates and relatively high relapse rates. The purpose of this study is to assess the safety and efficacy of combination therapy of fluconazole 1% and urea 40% compare with fluconazole 1% alone in a nail lacquer for treatment of onychomycosis caused by dermatophytes. 


This is a randomized, double-blind, study enrolling 70 patients with onychomycosis of the fingernails and toenails. Clinical and mycological efficacy as well as measures of safety was assessed monthly for a maximum of 6 months of treatment. We choose a total of 70 patients with severe toe and finger nails onychomycosis due to dermatophytes. The etiologic agents of onychomycosis were established by microscopic examination by potassium hydroxide solution (20%) and culture. The treatment regimens were: fluconazole 1% once daily for 6 months in 35 cases, and fluconazole 1% with urea 40% for 6 months in 35 cases.


 The high rates of clinical success achieved at the end of therapy in patients treated with fluconazole 1% with urea 40% about 64% and fluconazole 1% alone51%. Results of the treatment were followed up for 24 weeks. Thinning and total avulsion of the nails occurred in 87% of 66 patients with Dermatophytes onychomycosis and regrowth of a normal appearing nail was found in 82% of 48 patients.  Distal and lateral subungual onychomycosis was the most type of onychomycosis in this study (79.2%). Failure rate was 22.6% and recurrence rate was 12% in patients. Results of the treatment were followed up for 24 weeks. In this study topical treatment of onychomycosis with a combination of 1% fluconazole and 40% urea, was more effective than 1% fluconazole nail lacquer alone. Side effects were negligible.


  Topical antifungals can possibly better penetrate the thin nail plate. Fluconazole therapy is effective and safe alternative in treatment of onychomycosis due to Dermatophytes. Our study shows that treatment with fluconazole 1% and urea 40% (once daily for 6 month) is cost effective and safe in treating onychomycosis due to dermatophytes.

Subject Category: M. Mycology including clinical and basic studies of fungal infections

Shahindokht Bassiri-Jahromi , Pasteur Institute of Iran, Tehran, Iran
Amir Hooshang Ehsani, MD , Dermatology, Razi Hospital, Tehran, Iran
Mostafa Mirshams Shahshahani, MD , Dermatology, Razi Hospital, Tehran, Iran
Behrooz Jamshidi, PharmD , Razak Pharmacy Company, Tehran, Iran
Aref Amirkhani, PhD , Pasteur Institute of Iran, Tehran, Iran


S. Bassiri-Jahromi, Yes
Pasteur Institute of Iran: Grant Investigator and Member, Research grant

A. H. Ehsani, None

M. Mirshams Shahshahani, None

B. Jamshidi, Yes
Razac Company: Member and Research Contractor,

A. Amirkhani, None

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