Effect of 0.75% Piroctone Olamine Shampoo on the Hair and Scalp Microbiota of Hijab-Wearing Women With Seborrheic Dermatitis in Indonesia
NCT07802808 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2026-09-03
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.
Conditions
Interventions
- DRUG
-
Piroctone Olamine 0.75% Shampoo
Shampoo containing Piroctone Olamine 0.75%
- DRUG
-
Ketoconazole Shampoo, 2%
Ketoconazole shampoo
Sponsors & Collaborators
-
PT Paragon Technology and Innovation
collaborator UNKNOWN -
Indonesia University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 59 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-12
- Primary Completion
- 2026-02-02
- Completion
- 2026-02-02
Countries
- Indonesia
Study Locations
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