Comparison of Oral Itraconazole Pulse Therapy and Topical 2% Ketoconazole Shampoo for Moderate to Severe Scalp Seborrheic Dermatitis

What this Trial Is About

Researchers are evaluating treatments for moderate to severe scalp seborrheic dermatitis SD, a chronic inflammatory skin condition linked to Malassezia yeast that causes scaling, itching, and redness. This randomized controlled trial compares oral itraconazole pulse therapy to topical 2% ketoconazole shampoo to determine which better controls symptoms and prevents relapses. The study will enroll 80 participants aged 14 to 70 years with moderate to severe scalp SD. Participants are divided into two groups one group receives oral itraconazole in a pulse regimen over six months, starting with 100 mg twice daily for one week in the first month, then 100 mg twice daily for two days each month for five months. The other group uses 2% ketoconazole shampoo daily for 14 days followed by twice-weekly application for five months. Both treatments are given according to the study protocol to assess their effectiveness. Throughout the six-month study, participants will have their disease severity measured with the Scalp Seborrheic Dermatitis SSD score at baseline, 3 months, and 6 months. Clinical Global Impression CGI and Patient Global Impression PGI scales will assess treatment response and patient satisfaction. Side effects like nausea and dermatitis will be monitored. Data analysis will compare treatment effectiveness, relapse frequency, and patient satisfaction to guide better management of scalp SD.

The Effectiveness of Itraconazole Pulse Therapy vs Topical 2% Ketoconazole in the Treatment of Moderate to Severe Seborrheic Dermatitis of Scalp.