Clinical Research Directory

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

Sponsor: Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan

Summary

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.

Official title: The Effectiveness of Itraconazole Pulse Therapy vs Topical 2% Ketoconazole in the Treatment of Moderate to Severe Seborrheic Dermatitis of Scalp. A Randomized Control Trial

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