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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Seborrheic Dermatitis Severity Score from Baseline
研究概览
简要总结
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.
详细描述
Seborrheic dermatitis (SD) is a chronic, relapsing inflammatory skin disorder that primarily affects sebaceous gland-rich areas such as the scalp, face, chest, and upper back. It presents with greasy scales, erythema, itching, and dandruff, which can significantly impair quality of life. Globally, SD affects approximately 4.38% of the population, with higher prevalence in adults and males.
Although the exact pathogenesis remains unclear, strong evidence highlights the role of Malassezia species in disease development. These yeasts metabolize skin lipids, producing irritant free fatty acids (such as oleic acid), which trigger inflammatory pathways involving cytokines (IL-1β, IL-4, IL-8, IL-17) and NF-kB activation. Microbial imbalance, genetic predisposition (HLA associations), and links with systemic conditions (e.g., HIV, Parkinson's disease, psychiatric disorders) also contribute.
Rationale of the Study Current management focuses on symptom control and prevention of relapses. Antifungal therapies remain the cornerstone of treatment due to the central role of Malassezia.
Topical ketoconazole is widely used and effective but may cause local irritation in some patients.
Oral itraconazole offers both antifungal and anti-inflammatory effects and may provide better long-term control, especially in moderate to severe cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm B : Topical 2% ketoconazole shampoo
Participants receive topical 2% ketoconazole shampoo according to the study protocol for moderate to severe scalp seborrheic dermatitis.
干预措施: Ketoconazole 2% (Drug)
结局指标
主要结局
Change in Seborrheic Dermatitis Severity Score from Baseline
时间窗: Baseline and 4 weeks after initiation of treatment.
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.
次要结局
未报告次要终点
研究者
Sara Khan
Principal Investigator
Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan