Effectiveness and Safety of Topical Naftifine with Oral Itraconazole versus Topical Luliconazole with Oral Itraconazole for Superficial Fungal Skin Infections: A Multicenter Open-Label Study

An investigator initiated, multicenter, double arm, open-label observational study to compare the effectiveness and safety of the combination of topical Naftifine 2 percentage cream (OD) and oral Itraconazole 100mg (BID) versus the combination of topical Luliconazole 1 percentage cream (OD) and oral Itraconazole 100 mg (BID) in patients with superficial fungal skin infections (Tinea cruris & Tinea corporis) - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/09/074304

Enrollment

271

Registered

2024-09-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: B354- Tinea corporis Health Condition 2: B356- Tinea cruris

Interventions

Intervention1: Naftifine 2% cream (OD) and oral Itraconazole 100mg (BID): The intervention patients will be applying Naftifine 2% cream once daily and taking Itraconazole 100 mg orally twice daily for

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult Patient having tinea corporis or tinea cruris diagnosis based on clinical and/or mycological diagnosis. 2. Tinea cruris/corporis affecting more than 5% of the BSA. 3. The patient at the discretion of the treating physician is eligible to receive naftifine 2% cream or luliconazole 1% cream along with itraconazole 100mg (BID).

Exclusion criteria

Exclusion criteria: 1. Patients with a history of hypersensitivity to naftifine or luliconazole or oral itraconazole 2. Patients with uncontrolled co-morbidities like cardiac disorder, liver disorder, or renal disorder. 3. Any significant abnormality in liver function test (LFT), renal function test (RFT), and electrocardiogram (ECG), 4. Patients are not eligible to receive topical naftifine or topical luliconazole or oral itraconazole as per the prescribing information. 5. Pregnant or Lactating females. 6. Patient requiring additional antifungal other than study medication. 7. Any condition in which the study medication is not appropriate according to the treating physician. 8. Any patient who has received antifungal treatment and or topical corticosteroids within the last 1 month.

Design outcomes

Primary

Measure	Time frame
1.Proportion of patients achieving clinical cure at visit 4 (end of treatment) compared to the baseline.Timepoint: 1. from baseline to the end of treatment (six weeks)	—

Secondary

Measure	Time frame
1. Mycological cure 2. Adverse events reported during the study 3. Serious adverse events reported during the study 4. Overall tolerability evaluationTimepoint: 1. from baseline to the end of treatment (six weeks) 2. throughout the study 3. throughout the study 4. throughout the study	—

Countries

India

Contacts

Public ContactDr Anupam Das

Kali Pradip Chaudhuri Medical College

anupamdasdr@gmail.com9674852138

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026