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Treatment of fungal infection of skin with two antifungal drugs (terbinafine and itraconazole)

A comparative study of oral terbinafine versus oral itraconazole daily versus oral terbinafine and itraconazole daily versus oral terbinafine and itraconazole pulses in tinea

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/09/015843
Enrollment
200
Registered
2018-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue

Interventions

Intervention1: 1. Itraconazole daily 2. Terbinafine daily and itraconazole daily 3. Terbinafine daily and itraconazole pulse: 1. Itraconazole 5 mg /kg/day 2. Terbinafine 6 mg/kg/day and itraconazole 5

Sponsors

Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinically suspected tinea corporis, tinea cruris or tinea faciei or any combination of these 2. Confirmation of tinea by KOH microscopy Both criteria should be met.

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Lactation 3. Presence of any other type of tinea e.g. onychomycosis 4. Another skin disease at the site of tinea 5. Inability to come for follow ups 6. Intake of terbinafine or itraconazole in last 1 month 7. History of drug reaction or allergy to terbinafine or itraconazole 8. Present history of liver, renal or ischemic heart disease 9. Patients on treatment with drugs that have interaction with terbinafine or itraconazole 10. Patients requiring antihistamines due to co-existing skin disease e.g. urticaria 11. Abnormal complete blood count (for hemoglobin value taken as abnormal will be Any one criteria will exclude the patient.

Design outcomes

Primary

MeasureTime frame
Clinical and microscopic cure (i.e. complete clearance of lesions and negative KOH microscopy)Timepoint: 2 weeks, 4 weeks, 6 weeks, 8 weeks

Secondary

MeasureTime frame
Severity of itchingTimepoint: 2 weeks, 4 weeks, 6 weeks, 8 weeks

Countries

India

Contacts

Public ContactRadhika Raheja

Institute of Medical Sciences, Banaras Hindu University

sanjaye2@gmail.com0542-2309488

Outcome results

None listed

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