A Comparative study to test if combination of one topical and one oral drug with different mechanisms of action work better and decrease the duration of treatment in comparison with only one oral drug in treating fungal infections.

AN OPEN RANDOMIZED COMPARATIVE STUDY TO TEST THE EFFICACY AND SAFETY OF DAILY ORAL ITRACONAZOLE AS A MONOTHERAPY AND IN COMBINATION WITH TOPICAL AMOROLFINE IN TINEA CORPORIS/CRURIS.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/11/037863

Enrollment

300

Registered

2021-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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: ORAL ITRACONAZOLE 100MG BD with TOPICAL AMOROLFINE 0.25% OD : GROUP B:-Received systemic oral ITRACONAZOLE drug 100mg twice daily along with topical AMOROLFINE cream (0.25%)local appl

Eligibility

Inclusion criteria

Inclusion criteria: 1.Participants of 18-65 years and of both the sexes with active dermatophytic infection of skin. 2.Clinically supportive lesion(characteristic lesions are scaly circular, usually sharply marginated with a raised edge and an area of central clearing) 3.Evidence of fungal elements by positive KOH wet mount,positive fungal culture or both. 4.No history of application of any antifungal treatment or any local steroid atleast for a period of one month.

Exclusion criteria

Exclusion criteria: Patients who refused to give consent. Past known hypersensitivity to azole or morpholine compounds Patients with a known history of severe cardiac, pulmonary, gastrointestinal, renal, hepatic, neurological and uncontrolled diabetes mellitus. Patients who are immunocompromised ,taking immunosuppressant drugs, ,HIV infected or suffering from concomitant bacterial infections. Patients with contact dermatitis, atopic dermatitis, psoriasis or any other disease . Pregnant and lactating mothers. Negative for both KOH mount and fungal culture . Participants who are using antifungal agents for the disease in the past one month.

Design outcomes

Primary

Measure	Time frame
OUTCOME OF TREATMENT WILL BE MEASURED IN TERMS OF 1.DURATION OF TREATMENT REQUIRED FOR CLINICAL AND FUNGAL CLEARANCE 2.REDUCTION IN RELAPSE RATE Timepoint: 8 weeks for clinical and fungal clearance 12 weeks for reduction in relapse rate	—

Secondary

Measure	Time frame
SECONDARY OUTCOME OF TREATMENT WILL BE MEASURED IN TERMS OF 1.PATIENT SATISFACTION WITH TREATMENT 2.ADVERSE EFFECTS ASSOCIATED WITH TREATMENT Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactSakshi Gaba

Kalinga Institute of Medical Sciences

hkkar_2000@yahoo.com9868506372

Outcome results

None listed

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