"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"

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT138705301059N1

Enrollment

Registered

2009-02-09

Start date

2008-06-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

onychomycosis. Onychomycosis

Interventions

Intervention 1: Fluconazole 1% with urea 40% once daily for 6 monthes. Intervention 2: Fluconazole 1% once daily for 6 monthes.

Treatment - Drugs

Fluconazole 1% with urea 40% once daily for 6 monthes

Fluconazole 1% once daily for 6 monthes

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Onychomycosis treatment. Timepoint: One month before intervention,and at months 2, 4, and 6 after intervention. Method of measurement: Laboratory Examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahindokht Bassiri-Jahromi

Pasteur Institute of Iran

basiri@pasteur.ac.ir+98 21 6695 3311

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026