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
"The purpose of this study is to assess the safety and efficacy of combination therapy of fluconazole 1% and urea 40% comparing with fluconazole 1% alone in a nail lacquer for treatment of Onychomycosis caused by dermatophytes. In this double- blind study, 70 patients with mycologically confirmed onychomycosis will be randomize into treatment group (fluconazole 1% with urea 40%) or control group (fluconazole 1%) once daily for a maximum of 6 months. All patients should have the clinical diagnosis of distal subungual onychomycosis of the toenails confirmed mycologically by potassium hydroxid (KOH) wet mount and a positive culture for dermatophytes. Patients who have a nail with at least 25% involvement and at least 2 mm of healthy nail from the nail fold to the proximal onychomycotic border will be enrolled in the study. Patients with hypersensitivity to the azole class of compounds; those who have been treated with systemic oral antifungal drugs, Within 3 months, or any investigational drug within one month before enrolling in the study will be excluded. Patients who are clinically cured or improved at the end of therapy will be followed for a 6-month follow-up period and will be assessed at 2, 4, and 6 months after treatment. Patients who are diagnosed as treatment failure at the end of treatment period would not be followed."
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138705301059N1
Registration date:2009-02-09, 1387/11/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-02-09, 1387/11/21
Registrant information
Name
Shahindokht Bassiri-Jahromi
Name of organization / entity
Pasteur Institute of Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 3311
Email address
basiri@pasteur.ac.ir
Recruitment status
Recruitment complete
Funding source
Pasteur Institute of Iran
Expected recruitment start date
2008-06-22, 1387/04/02
Expected recruitment end date
2009-08-22, 1388/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
"Assessment of the efficacy and safety of combination therapy of fluconazole 1% and urea 40% comparing with fluconazole 1% alone in the treatment of onychomycosis"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of at least 25% involvement of the target nail, at least 2 mm of healthy nail from the nail fold to the proximal Dermatophyte onychomycosis border. Exclusion criteria: Non-dermatophytic onychomycosis, hypersensitivity to Azole derivatives, unwilling to sign informed consent, receiving systemic anti-fungal treatment or any investigational drug during three month prior to study