Comparison of Itraconazole With Itraconazole and Isotretinoin in the Treatment Duration, Safety a n d Cure Rate in Adult Patients of Tinea Corporis/ Cruris-A Randomised Controlled Trail

Phase 4Not Yet RecruitingNCT07675239

Pak Emirates Military Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Tinea Corporis

Interventions

Eligibility

Sex: ALLMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.