Health Condition 1: B351- Tinea unguium
Conditions
Interventions
Intervention1: Fractional CO2 laser: Once per month for 6 months
Control Intervention1: Oral itrazonazole
Ciclopirox 5% nail lacquer: 200mg BD for 1 week/month for 2-4 months
Daily application for 12
Sponsors
Anwesha Moharana
Eligibility
Inclusion criteria
Inclusion criteria: 1.Confirmed diagnosis of onychomycosis based on 2/4 investigations being positive. 2. Moderate to severe onychomycosis involving at least two nails 3. Normal kidney and liver function 4. Consenting to adhere to the study protocol, and complete the requisite follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant And lactating females 2. Presence of liver disease, renal impairment or cardiac disease 3. History of recent systemic or topical antifungal treatment 4. Secondary onychomycosis 5. Uncontrolled diabetes or immunocompromised status 6. Active bacterial or viral infections around nail 7. History of hypersensitivity to the systemic and topical antifungals drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significance of difference in the decline in OSI score between laser-treated and laser-untreated nails.Timepoint: At 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in mycological cure rates between the two groups at treatment end-pointTimepoint: 6 months;Difference in recurrence rates between the two groups at follow-up end pointTimepoint: 12 months;Difference in Physician Global Assessment scale in both groupsTimepoint: 6 months and 12 months;Frequency of treatment related adverse effectsTimepoint: ;Correlation of mycological cure rates and recurrence rates with the etiological fungiTimepoint: | — |
Countries
India
Contacts
Public ContactAnwesha Moharana
University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi
Outcome results
None listed