Comparative study of oral Itraconazol 200mg vs Terbinafine 500mg in treatment of fungal infection of skin

Single blind randomized parallel assignment comparative study to access efficacy and safety of oral Itraconazol 200mg versus oral Terbinafine 500mg in cutaneous dermatophytic infections involving non glabrous skin excluding scalp and nail.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/09/009767

Enrollment

100

Registered

2017-09-14

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: null- Dermatophytic Skin Infection of Non glabrous skin excluding Scalp and Nail

Interventions

Intervention1: nil: nil Control Intervention1: Tablet Terbinafine 500mg for 14 days.: Used for Dermatophytic skin infections Control Intervention2: Capsule Itraconazol 200mg for 14 days: used for Derm

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex age between 18 to 60 years 2. Presence fungus in scrapping taken from lesion by in KOH preparation. 3. Women of child bearing age must have a negative urine pregnancy test and should agree to use effective contraceptive measures during study. 4. Patient willing to give written informed consent for study including 7 days wash out period.

Exclusion criteria

Exclusion criteria: 1. Patient less than 18 year age and more than 60 year. 2. Preexisting Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, musculoskeletal, neurological or psychiatric disease. 3. Alcohol dependence, alcohol abuse or drug abuse within past one year. 4. Moderate to heavy smoking ( >10 cigarettes/day) or consumption of tobacco products 5. Clinically significant illness within 4 weeks before the start of the study 6. Asthma, urticaria or other allergic type reactions after taking any medication 7. Pregnant and lactating women 8. Patient having pre existing medical condition (DM HT or any other medical condition requiring concomitant medicine.) or diagnosed during screening. 9. Patients having any of absolute or relative contraindication to use of oral Itraconazol and Oral Terbinafine. 10. Clinically diagnosed as deratophytic skin infection but negative for fungus in KOH examination. 11. Dermatophytosis independently or concomitantly involving scalp and nail 12. Patients having skin lesions with secondary bacterial infections.

Design outcomes

Primary

Measure	Time frame
Clinical response rate at 21+/- 2 days for both groups will be evaluated using physician global assessment .Any adverse event reported by patient at day at any point of time in study and change in laboratory parameter at day 21+/-2 will be evaluated.Timepoint: Clinical response rate at 21+/- 2 days for both groups will be evaluated using physician global assessment .Any adverse event reported by patient at day at any point of time in study and change in laboratory parameter at day 21+/-2 will be evaluated.	—

Measure

Time frame

Clinical response rate at 21+/- 2 days for both groups will be evaluated using physician global assessment .Any adverse event reported by patient at day at any point of time in study and change in laboratory parameter at day 21+/-2 will be evaluated.Timepoint: Clinical response rate at 21+/- 2 days for both groups will be evaluated using physician global assessment .Any adverse event reported by patient at day at any point of time in study and change in laboratory parameter at day 21+/-2 will be evaluated.

—

Secondary

Measure	Time frame
clinical and mycological relapse rate at day 35Timepoint: day 35	—

Countries

India

Contacts

Public ContactDrNayankumar H Patel

GCS Medical College, Hospital & Research Centre

patelnayan78.np@gmail.com07966048035

Outcome results

None listed

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