Effect of 0.75% Piroctone Olamine Shampoo on the Hair and Scalp Microbiota of Hijab-Wearing Women With Seborrheic Dermatitis in Indonesia
2026年8月31日 更新者：Dr. dr. Lili Legiawati, SpKK(K)、Indonesia University
Effects of 0.75% Piroctone Olamine Shampoo on Hair and Scalp Microbiota in Hijab-Wearing Women With Seborrheic Dermatitis: A Randomized, Controlled, Double-Blind Clinical Trial
The goal of this clinical trial is to learn whether piroctone olamine shampoo works as well as ketoconazole shampoo to improve seborrheic dermatitis (dandruff) in hijab-wearing women in Indonesia. It will also assess the safety of piroctone olamine shampoo. The main questions it aims to answer are:
- Does piroctone olamine shampoo improve the signs and symptoms of seborrheic dermatitis?
- Does piroctone olamine shampoo cause any scalp or hair-related side effects?
Researchers will compare piroctone olamine shampoo with ketoconazole shampoo to assess their effects on seborrheic dermatitis.
Participants will:
- Attend screening and study visits for scalp and hair examinations.
- Use either piroctone olamine shampoo or ketoconazole shampoo as instructed during the study.
- Provide hair and scalp samples for microbiota testing and superoxide dismutase testing.
- Have scalp hydration, water loss, and sebum levels measured.
- Report any discomfort, scalp irritation, or other side effects during the study.
研究概览
详细说明
The goal of this clinical trial is to learn the effectivity and safety of piroctone olamine shampoo in Hijab-wearing women with seborrheic dermatitis in Indonesia. The main question it aims to answer is:
Does piroctone olamine shampoo improve clinical signs and symptoms of seborrheic dermatitis and demonstrate comparable safety to ketoconazole shampoo in hijab-wearing women with seborrheic dermatitis?
Researchers will compare piroctone olamine shampoo with ketoconazole shampoo to determine whether piroctone olamine shampoo improves seborrheic dermatitis in hijab-wearing women.
Participants will:
- Be screened to confirm eligibility and provide written informed consent before any study procedures.
- Undergo baseline assessment of seborrheic dermatitis, including clinical evaluation of the scalp and hair.
- Provide hair and scalp samples for microbiota analysis and superoxide dismutase level testing
- Undergo scalp assessments, including skin capacitance, transepidermal water loss (TEWL), and scalp sebum measurements.
- Be assigned to use either piroctone olamine shampoo or ketoconazole shampoo according to the study instructions.
- Use the assigned shampoo for the specified treatment duration and follow the scheduled shampoo-use instructions.
- Attend scheduled follow-up visits for clinical reassessment of seborrheic dermatitis and repeat scalp and hair measurements.
- Report any discomfort, irritation, allergic reaction, or other adverse events experienced during the study.
- Complete the final study visit, including final clinical, microbiota, scalp hydration, TEWL, and sebum assessments.
研究类型
介入性
注册 (实际的)
86
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Jakarta、印度尼西亚、10430
- dr. Cipto Mangunkusumo General Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Hijab-wearing women with mild, moderate, or severe seborrheic dermatitis.
- Aged 18 to 59 years.
- Willing to participate in the study and able to provide written informed consent
Exclusion Criteria:
- Diagnosis of another hair or scalp condition, such as alopecia, trichotillomania, malignancy, or scalp infection, based on medical history.
- Current use of medication or treatment for the hair or scalp.
- Current use of cytostatic therapy for malignancy or other cytostatic medications.
- Known hypersensitivity to the shampoo base or any of its ingredients, based on medical history.
- Pregnancy or breastfeeding.
- Current use of additional hair or scalp-care products.
- History of liver disease, kidney disease, vitiligo, or psoriasis, based on medical history.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention
Piroctone Olamine 0.75% Shampoo
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Shampoo containing Piroctone Olamine 0.75%
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有源比较器：Comparator (First Line Therapy)
Ketoconazole Shampoo
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Ketoconazole shampoo
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Relative Abundance of Prespecified Hair and Scalp Microbiota
大体时间：Baseline, Week 2
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Relative abundance of prespecified bacterial and fungal species in hair and scalp samples, including Malassezia restricta, Staphylococcus capitis, and Cutibacterium acnes, will be assessed before and after the intervention.
Relative abundance will be compared between participants assigned to 0.75% piroctone olamine shampoo and participants assigned to 2% ketoconazole shampoo.
|
Baseline, Week 2
|
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Change in Seborrheic Dermatitis Severity Measured by the 16-Point Scale
大体时间：Baseline, Week 2
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Seborrheic dermatitis severity of the hair and scalp will be assessed using the 16-point clinical severity scale.
The change in total score from baseline to the follow-up assessment will be compared between the 0.75% piroctone olamine shampoo group and the 2% ketoconazole shampoo group.
Higher scores indicate greater clinical severity.
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Baseline, Week 2
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Change in Scalp Skin Capacitance
大体时间：Baseline, Week 2
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Scalp skin capacitance, an instrumental measure of stratum corneum hydration, will be measured using Corneometer.
Change from baseline to the follow-up assessment will be compared between the 0.75% piroctone olamine shampoo group and the 2% ketoconazole shampoo group.
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Baseline, Week 2
|
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Change in Scalp Transepidermal Water Loss
大体时间：Baseline, Week 2
|
Scalp transepidermal water loss (TEWL) will be measured using Tewameter.
Change from baseline to the follow-up assessment will be compared between the 0.75% piroctone olamine shampoo group and the 2% ketoconazole shampoo group.
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Baseline, Week 2
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Change in Scalp Sebum Level
大体时间：Baseline, Week 2
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Scalp sebum level will be measured using Sebumeter.
Change from baseline to the follow-up assessment will be compared between the 0.75% piroctone olamine shampoo group and the 2% ketoconazole shampoo group.
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Baseline, Week 2
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Change in Scalp Superoxide Dismutase (SOD) Level
大体时间：Baseline, Week 2
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Scalp superoxide dismutase (SOD) level will be measured in scalp samples collected at baseline and at the post-treatment assessment using the prespecified laboratory assay.
The change in SOD level from baseline will be compared between participants assigned to 0.75% piroctone olamine shampoo and those assigned to 2% ketoconazole shampoo.
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Baseline, Week 2
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月12日
初级完成 (实际的)
2026年2月2日
研究完成 (实际的)
2026年2月2日
研究注册日期
首次提交
2026年8月31日
首先提交符合 QC 标准的
2026年8月31日
首次发布 (实际的)
2026年9月3日
研究记录更新
最后更新发布 (实际的)
2026年9月3日
上次提交的符合 QC 标准的更新
2026年8月31日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.