Comparing two medications (itraconazole and isotretinoin) in treating fungal infection.

Comparison of the efficacy of oral itraconazole alone versus combination of oral itraconazole with isotretinoin in treatment of tinea infection

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000004369

Enrollment

Registered

2026-01-06

Start date

2025-08-01

Completion date

2025-11-30

Last updated

2026-01-12

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

Conditions

None listed

Brief summary

Study design; Randomised Control Trial Intervention Description; A comparative study of oral itraconazole 200mg /day versus oral itraconazole 200mg/day with oral isotretinoin 20mg daily for duration of 8 weeks in treatment of tinea infection, will be conducted at Dermatology out-patient department, PNS Shifa hospital, Karachi. After written consent, 94 patients will be divided into GROUP A and B. Patients in both the groups will recieve treatment for 8 weeks and data from the patient will be collected through a proforma on first visit and follow-ups. Evaluation will be done through Total Symptom Score (TSS) at baseline(week 0), 4 weeks and 8 weeks after commencement of treatment. Improvement will be assessed by clinician as follows: Excellent Response: 80-100% improvement Moderate Response: 50-79% improvement Failure : <50% improvement Hypothesis; Proposition of this study is based on the belief that there is difference between the efficacies of oral itraconazole alone compared with the addition of oral isotretinoin in management of tinea infection.

Interventions

Group B : daily dose of oral Itraconazole 200mg together with 20mg/day of oral isotretinoin for duration of 8 weeks.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

• Tinea infection [confirmed on the basis of clinical findings having itchy, erythematous and scaly skin lesions with advancing borders along with a positive 10 % KOH (potassium hydroxide) preparation test for direct microscopic examination showing fungal hyphal filaments.] • Patients with tinea faciei, corporis, cruris or tinea manuum and pedis. • Age between 18-75 years. • Patients of both genders

Exclusion criteria

• Patients with tinea capitis and onychomycosis. • Patients with renal and chronic liver diseases. • Patients with coronary heart diseases and hyperlipidemia. • Patients with uncontrolled diabetes mellitus. • Patients with uncontrolled hypertension. • Those on chronic immunosuppressive therapy. • Pregnant and lactating women. • Elderly patients (>75 YEARS)

Outcome results