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COMPLETED
NCT07802808
PHASE4

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

Sponsor: Indonesia University

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2026-01-12

Completion Date

2026-02-02

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

DRUG

Piroctone Olamine 0.75% Shampoo

Shampoo containing Piroctone Olamine 0.75%

DRUG

Ketoconazole Shampoo, 2%

Ketoconazole shampoo

Locations (1)

dr. Cipto Mangunkusumo General Hospital

Jakarta, Indonesia