A Phase 4 interventional study of Itraconazole (200 mg) and ISOtretinoin 20 MG in Tinea Corporis, sponsored by Pak Emirates Military Hospital. Not yet recruiting at 1 site in Pakistan. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Pak Emirates Military Hospital · Phase 4, Interventional, and Treatment
Tinea corporis and tinea cruris are common superficial fungal infections that have become increasingly difficult to treat because of prolonged disease duration, frequent recurrences, and suboptimal response to standard antifungal therapy. Itraconazole is widely used for the treatment of dermatophytosis; however, treatment failures and relapses remain a significant concern. Isotretinoin has been proposed as an adjuvant therapy because of its effects on epidermal differentiation, keratinization, and follicular function, which may enhance antifungal penetration and improve treatment outcomes.
This randomized controlled trial aims to compare itraconazole monotherapy with a combination of itraconazole and isotretinoin in adult patients with tinea corporis and/or tinea cruris. The study will evaluate treatment duration, cure rate, and safety profile of both regimens. The findings may provide evidence regarding the potential benefit of adding isotretinoin to conventional antifungal therapy and help optimize management strategies for adult patients with dermatophytosis.
39 studies on the registry are indexed under Tinea; 8 are open to participants now.
This study's planned enrollment of 60 is close to the median of 64 across 33 interventional studies indexed under Tinea.
Browse Tinea studies →Pak Emirates Military Hospital is the lead sponsor of 24 studies on the registry; 12 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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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Participants receive oral itraconazole according to the study protocol for the treatment of tinea corporis/cruris. Clinical and mycological responses are assessed during follow-up.
Drug: Itraconazole (200 mg)
Participants receive oral itraconazole in combination with low-dose oral isotretinoin according to the study protocol for the treatment of tinea corporis/cruris. Clinical and mycological responses are assessed during follow-up.
Drug: Itraconazole (200 mg) · Drug: ISOtretinoin 20 MG
Oral itraconazole 200 mg daily administered to adult patients with tinea corporis/cruris. Treatment is continued according to the study protocol, and participants are monitored for clinical improvement, mycological cure, adverse events, and recurrence.
Oral isotretinoin 20 mg daily administered in combination with oral itraconazole 200 mg daily to adult patients with tinea corporis/cruris. Participants are monitored for treatment response, mycological cure, adverse events, and recurrence according to the study protocol.
Treatment Duration to Complete Cure
Treatment duration (in weeks) required to achieve complete cure, defined as complete clinical resolution of signs and symptoms of tinea corporis/cruris along with negative KOH microscopy. The outcome will be compared between the itraconazole monotherapy group and the itraconazole plus isotretinoin group.
Time frame: 8 weeks
Treatment related adverse events
Frequency and severity of adverse events associated with treatment, including headache, abdominal pain, mucocutaneous dryness, jaundice, liver function test abnormalities, lipid profile abnormalities, and thyroid function abnormalities.
Time frame: 8 weeks
Plan to share: No — Individual participant data (IPD) will not be shared because the study was not designed with participant-level data sharing provisions, and sharing such data may compromise participant confidentiality and privacy. Only aggregated study results will be reported and published.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Isotretinoin
Pak Emirates Military Hospital