A Post marketing comparative study of three topical medications, Setaconazole 2%, Terbinafine 1% and Luliconazole 1% in patients with fungal infections of the skin

Comparative assessment of efficacy, safety and tolerability of Sertaconazole nitrate 2% cream vs terbinafine cream 1% vs luliconazole 1% cream in Patients with cutaneous mycoses

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2010/091/003026

Enrollment

Registered

2010-11-29

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- Cutaneous Mycoses

Interventions

Intervention1: Sertaconazole 2% topical: 2% cream twice daily for two or 4 weeks Control Intervention1: Terbinafine 1% topical: 1% cream once daily Control Intervention2: Luliconazole 1% topical: 1% c

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Male & female (post-menopausal, surgically sterilized or practicing a reliable method of birth control) patients with age ranging from 18 to 70 years. 2. Clinical diagnosis of tinea infections, confirmed by laboratory evaluation (microscopic examination confirmed by a positive potassium hydroxide [KOH] test) with inflammatory dermatoses. 3. Written informed consent by patient. 4. Patient willing to follow up.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: (excluded if any of the answers is ?YES?) 1. Pregnant or lactating women 2. Patients who had received oral treatment with antimycotics during the 4 weeks preceding the trial or topical treatment during the week before 3. Patients with compromised immunity (patients taking steroid, immunosuppresants or with HIV/AIDS) 4. Bacterial skin infection 5. Applied topical antifungal therapy to the feet within 14 days of study or had been treated with oral antifungal therapies within 3 months of study entry. 6. Hypersensitivity to Sertaconazole nitrate, beclomethasone dipropionate, miconazole or base of cream. 7. Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study.

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of Sertaconazole nitrate 2 cream vs terbinafine 1% cream and luliconazole 1% cream in adult patients with cutaneous mycosesTimepoint: 6 weeks	—

Secondary

Measure	Time frame
To assess the safety and short term tolerability of Sertaconazole nitrate 2 cream vs terbinafine 1% cream and luliconazole 1% cream in adult patients with cutaneous mycosesTimepoint: 4 weeks	—

Countries

India

Contacts

Public ContactDr H R Jerajani

jerajani@rediffmail.com24044774

Outcome results

None listed

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