This study is a randomized controlled trial comparing the effectiveness of oral itraconazole pulse therapy versus topical 2% ketoconazole shampoo in treating moderate to severe scalp seborrheic dermatitis (SD). SD is a chronic inflammatory skin condition associated with Malassezia yeast, characterized by scaling, itching, and redness, significantly affecting quality of life.
A total of 80 participants aged (14-70 years) with moderate to severe scalp SD will be enrolled and divided into two groups. Group A will receive oral itraconazole (pulse regimen over 6 months), while Group B will use ketoconazole shampoo (initial daily use followed by twice weekly application). Outcomes will be assessed using the Scalp Seborrheic Dermatitis (SSD) score, Clinical Global Impression (CGI) scale, and Patient Global Impression (PGI) scale.
The study aims to compare:
Treatment effectiveness Frequency of disease relapses Patient satisfaction Side-effect profiles Data will be analyzed using statistical tests (t-tests and chi-square), with significance set at p \< 0.05.
The hypothesis is that oral itraconazole pulse therapy is more effective than topical ketoconazole in controlling symptoms and preventing relapses in scalp SD.
Patients who are interested in taking part in research are between the ages of 14-17 with people who have scalp SD ranging from moderate to severe.
Patients with heart disease. Pregnant women or lactating women liver disease patients as itraconazole can be hepatotoxic uncontrolled hypertension patient taking multiple drugs like oral antidiabetics, lipid lowering drugs, sedatives patient has history to hypersensitvity to either of drugs.
Parallel
Itraconazole (200 mg)
DrugOral itraconazole administered as pulse therapy according to the study protocol.
Ketoconazole 2%
DrugKetoconazole 2% shampoo applied to the scalp twicw weekly for 4 weeks according to the study protocol.
Change in Seborrheic Dermatitis Severity Score from Baseline
To compare the effectiveness of itraconazole pulse therapy versus topical 2% ketoconazole shampoo in reducing the severity of moderate to severe scalp seborrheic dermatitis using Seborrheic Dermatitis Severity Score.
Click on the lead sponsor to view all of their trials.
