Comparison of Itraconazole With Itraconazole and Isotretinoin in the Treatment Duration, Safety, and Cure Rate in Adult Patients With Tinea Corporis/Cruris: A Randomized Controlled Trial.
| Registry | NCT07675239 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 60 (Estimated) |
| Sponsor | Pak Emirates Military Hospital (Other) |
| Conditions | Tinea Corporis |
| Interventions | Itraconazole (200 mg), ISOtretinoin 20 MG (Drug) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-03-01 (estimated), completion 2027-03-01 (estimated), first posted 2026-06-30, last updated 2026-06-30 |
| Locations | 1 site in Pakistan |
Related Papers Related Patents Related Grants Related Experts
All trials for Tinea Corporis All trials of Itraconazole (200 mg) All trials of ISOtretinoin 20 MG
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Oral itraconazol 200mg | Active comparator | Drug: Itraconazole (200 mg) | 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. |
| Itraconazole Plus Isotretinoin | Experimental | Drug: Itraconazole (200 mg); Drug: ISOtretinoin 20 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. |
Sex: All, ages: any to 75 Years
Inclusion Criteria: * Al newly diagnosed cases with typical tinea lesion involving at least 5% body surface area (BSA) with no nail/scalp/palm/sole involvement and no history of intake of any oral antifungal in the preceding 4 weeks or of a topical antifungal/steroid in the preceding 2 weeks. Presenting to the outpatient department or the emergency department of PEMH or CMH will be included in the study. Exclusion Criteria: * 1\. Patients with chronic liver and renal diseases. 2. Patients with ischaemic heart diseases. 3. Patients with hyperlipidemia. 4. 5. Those on chronic immunosuppressive therapy. Pregnant and lactating women and females of reproductive age. 6. Elderly patients above 75 years 7. Patient who had taken oral antifungal in the preceding 4 weeks or of a topical antifungal/steroid in the preceding 2 weeks
| Facility | City | Country | Status |
|---|---|---|---|
| PakEmirates | Rawalpindi, Punjab Province | Pakistan |