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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change in Relative Abundance of Prespecified Hair and Scalp Microbiota
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intervention
Piroctone Olamine 0.75% Shampoo
干预措施: Piroctone Olamine 0.75% Shampoo (Drug)
Comparator (First Line Therapy)
Ketoconazole Shampoo
干预措施: Ketoconazole Shampoo, 2% (Drug)
结局指标
主要结局
Change in Relative Abundance of Prespecified Hair and Scalp Microbiota
时间窗: Baseline, Week 2
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.
Change in Seborrheic Dermatitis Severity Measured by the 16-Point Scale
时间窗: Baseline, Week 2
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.
Change in Scalp Skin Capacitance
时间窗: Baseline, Week 2
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.
Change in Scalp Transepidermal Water Loss
时间窗: 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.
Change in Scalp Sebum Level
时间窗: Baseline, Week 2
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.
Change in Scalp Superoxide Dismutase (SOD) Level
时间窗: Baseline, Week 2
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.
次要结局
未报告次要终点
研究者
Dr. dr. Lili Legiawati, SpKK(K)
Prof. Dr. dr.
Indonesia University