Effect of 0.75% Piroctone Olamine Shampoo on the Hair and Scalp Microbiota of Hijab-Wearing Women With Seborrheic Dermatitis in Indonesia

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:

1. Does piroctone olamine shampoo improve the signs and symptoms of seborrheic dermatitis?
2. 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:

1. Attend screening and study visits for scalp and hair examinations.
2. Use either piroctone olamine shampoo or ketoconazole shampoo as instructed during the study.
3. Provide hair and scalp samples for microbiota testing and superoxide dismutase testing.
4. Have scalp hydration, water loss, and sebum levels measured.
5. Report any discomfort, scalp irritation, or other side effects during the study.

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:

1. Be screened to confirm eligibility and provide written informed consent before any study procedures.
2. Undergo baseline assessment of seborrheic dermatitis, including clinical evaluation of the scalp and hair.
3. Provide hair and scalp samples for microbiota analysis and superoxide dismutase level testing
4. Undergo scalp assessments, including skin capacitance, transepidermal water loss (TEWL), and scalp sebum measurements.
5. Be assigned to use either piroctone olamine shampoo or ketoconazole shampoo according to the study instructions.
6. Use the assigned shampoo for the specified treatment duration and follow the scheduled shampoo-use instructions.
7. Attend scheduled follow-up visits for clinical reassessment of seborrheic dermatitis and repeat scalp and hair measurements.
8. Report any discomfort, irritation, allergic reaction, or other adverse events experienced during the study.
9. Complete the final study visit, including final clinical, microbiota, scalp hydration, TEWL, and sebum assessments.

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.