Effect of 0.75% Piroctone Olamine Shampoo on the Hair and Scalp Microbiota of Hijab-Wearing Women With Seborrheic Dermatitis in Indonesia
31 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
86
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
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Jakarta, Indonesia, 10430
- dr. Cipto Mangunkusumo General Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention
Piroctone Olamine 0.75% Shampoo
|
Shampoo containing Piroctone Olamine 0.75%
|
|
Comparador activo: Comparator (First Line Therapy)
Ketoconazole Shampoo
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Ketoconazole shampoo
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Relative Abundance of Prespecified Hair and Scalp Microbiota
Periodo de tiempo: 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.
|
Baseline, Week 2
|
|
Change in Seborrheic Dermatitis Severity Measured by the 16-Point Scale
Periodo de tiempo: 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.
|
Baseline, Week 2
|
|
Change in Scalp Skin Capacitance
Periodo de tiempo: 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.
|
Baseline, Week 2
|
|
Change in Scalp Transepidermal Water Loss
Periodo de tiempo: 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.
|
Baseline, Week 2
|
|
Change in Scalp Sebum Level
Periodo de tiempo: 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.
|
Baseline, Week 2
|
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Change in Scalp Superoxide Dismutase (SOD) Level
Periodo de tiempo: 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.
|
Baseline, Week 2
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
12 de enero de 2026
Finalización primaria (Actual)
2 de febrero de 2026
Finalización del estudio (Actual)
2 de febrero de 2026
Fechas de registro del estudio
Enviado por primera vez
31 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de agosto de 2026
Publicado por primera vez (Actual)
3 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KET459UN2F1ETIKPPM00022025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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