A comparison of oral Terbinafine and Itraconazole in stubborn Tinea infections

A Prospective , Randomized , Open Label Study To Evaluate The Efficacy And Safety Of Systemic Terbinafine And Topical Amorolfine Compared to Systemic Itraconazole And Topical Amorolfine In Adult Patients Of Recalcitrant Tinea Cruris

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/07/019964

Enrollment

100

Registered

2019-07-01

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: B356- Tinea cruris

Interventions

Intervention1: Terbinafine and Amorolfine: Terbinafine 250 mg OD orally daily and local application of 0.25% Amorolfine BD daily to one group for 8 weeks Control Intervention1: Itraconazole and Amoro

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with recalcitrant Tinea Cruris 2. Patients willing to give informed consent and comply with the treatment and follow up

Exclusion criteria

Exclusion criteria: 1. 65 years age 2. Pregnant or Lactating women 3. Secondary bacterial infections 4. Deep mycosis 5. Immunocompromised patients- Severe uncontrolled Diabetes, HIV/AIDS, chronic glucocorticoid therapy 6. Patients with abnormal liver function and kidney function test 7. Present or past history of malignancy 8. Patients with known history of allergy to Itraconazole or Terbinafine or related drugs 9. patients with history of ischemic heart disease 10. Patients not giving informed consent

Design outcomes

Primary

Measure	Time frame
To compare safety and efficacy of Itraconazole and Terbinafine in achieving complete cure in recalcitrant tinea cruris infections by 4 point rating scaleTimepoint: 2,4,6,8,10,12 weeks	—

Secondary

Measure	Time frame
Compare adverse effect profile of Itraconazole and TerbinafineTimepoint: 2,4,6,8,10,12 weeks;To assess the non-responders, if anyTimepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Vasudha Sharma

Government Medical College , Amritsar

navyug69@gmail.com9878634358

Outcome results

None listed

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