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Treatment for fungal infection of nails

Randomized, double blind, comparative study on efficacy and safety of itraconazole pulse therapy and terbinafine pulse therapy in the treatment of non-dermatophyte onychomycosis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2013/013
Enrollment
Unknown
Registered
2013-03-27
Start date
2013-05-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Non-dermatophyte onychomycosis

Interventions

Consenting patients will be randomized into two arms. The first arm (A) will receive oral Itraconazole pulse therapy (i.e. itraconazole 200 mg twice daily for 7 days per month
1 week on and 3 weeks off). Two pulses will be given for fingernail infections and three pulses for toenail infections. The second arm (B) will receive Terbinafine pulse therapy: terbinafine 250mg twi
1 week on and 3 weeks off). Two pulses will be given for fingernail infections and three pulses for toenail infections

Sponsors

Base Hospital Homagama
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients with non-dermatophyte mycology as confirmed by fungal studies will be recruited

Exclusion criteria

Exclusion criteria: 1. >12 years of age 2. pregnancy 3. breast feeding 4. known renal impairment 5. known liver impairment 6. congestive cardiac failure

Design outcomes

Primary

MeasureTime frame
Clinical cure (morphologically normal nail) [At 12 weeks for fingernail infections and 16 weeks for toenail infections] Mycological cure (negative light microscopic examination [KOH] and negative fungal culture) [At 12 weeks for fingernail infections and 16 weeks for toenail infections]

Secondary

MeasureTime frame
Long term clinical cure (morphologically normal nail) [For fingernail infections: every 12 weeks for a total 14 months For toenail infections: every 12 weeks for a total 15 months ] Long term Mycological cure (negative light microscopic examination [KOH] and negative fungal culture) [For fingernail infections: every 12 weeks for a total 14 months For toenail infections: every 12 weeks for a total 15 months ]

Countries

Sri Lanka

Contacts

Public ContactRanthilaka Ranawaka

Consultant Dermatologist

ranthilaka37@yahoo.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026