A Phase 4 interventional study of Itraconazole and Luliconazole Cream 1% in Tinea Corporis,Tinea Cruris,Tinea Faciei, sponsored by University of Faisalabad. Not yet recruiting at 2 sites in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Faisalabad · Phase 4, Interventional, and Treatment
The goal of this randomized controlled trial is to compare the efficacy of topical luliconazole with topical bifonazole in adults aged 18-60 years with dermatophytosis. All participants will receive oral itraconazole, while either topical luliconazole or topical bifonazole will be added according to their assigned treatment group. The main questions it aims to answer are:
Participants will:
Dermatophytosis is a superficial fungal infection caused by dermatophytes and commonly affects keratinized tissues such as the skin. In this study, dermatophytosis refers specifically to tinea faciei, tinea corporis, and tinea cruris.
Itraconazole is an oral antifungal commonly used in the treatment of dermatophytosis. Bifonazole is a topical antifungal that has been used for the treatment of dermatophyte infections, while luliconazole is a newer topical antifungal agent with activity against dermatophytes.
There is limited direct clinical evidence comparing topical luliconazole with topical bifonazole when both are used along with oral itraconazole. In this study, oral itraconazole will be given to both groups, while the topical antifungal will differ. This will allow a direct comparison of the efficacy of topical luliconazole and topical bifonazole.
The study will be conducted as an open-label randomized controlled trial at the Department of Dermatology, Madinah Teaching Hospital, Faisalabad. The clinical and mycological outcomes of the two treatment groups will be compared.
39 studies on the registry are indexed under Tinea; 8 are open to participants now.
This study's planned enrollment of 182 is above the median of 64 across 33 interventional studies indexed under Tinea.
Browse Tinea studies →University of Faisalabad is the lead sponsor of 86 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive oral itraconazole 100 mg twice daily for 28 days together with topical luliconazole 1% cream once daily for 28 days.
Drug: Itraconazole · Drug: Luliconazole Cream 1%
Participants will receive oral itraconazole 100 mg twice daily for 28 days together with topical bifonazole 1% cream once daily for 28 days.
Drug: Itraconazole · Drug: Bifonazole cream 1%
Itraconazole 100 mg orally twice daily for 28 days. It will be administered to participants in both treatment groups.
Luliconazole 1% cream applied topically once daily for 28 days to the affected areas.
Bifonazole 1% cream applied topically once daily for 28 days to the affected areas.
Mean reduction in DeASI score from baseline to Week 4
Mean reduction in Dermatophytosis Area and Severity Index (DeASI) score from baseline to Week 4, assessed by clinical examination and DeASI scoring.
Time frame: Baseline to Week 4
Proportion of patients with negative 10% KOH microscopy at Week 4
Proportion of patients with negative 10% KOH microscopy at Week 4 after treatment.
Time frame: Week 4
Proportion of patients with relapse at Week 6
Proportion of patients with relapse at Week 6 after treatment.
Time frame: Week 6
Plan to share: No — Individual participant data will not be shared with other researchers because the study data will be maintained by the research team for the purposes of this study, with participant confidentiality and privacy protected.
Start is estimated for Dec 2026; primary completion for Jul 2027, 7 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Luliconazole
University of Faisalabad