A Phase 4 interventional study of Piroctone Olamine 0.75% Shampoo and Ketoconazole Shampoo, 2% in Seborrheic Dermatitis, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to female participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Indonesia University · Phase 4, Interventional, and Treatment
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:
Researchers will compare piroctone olamine shampoo with ketoconazole shampoo to assess their effects on seborrheic dermatitis.
Participants will:
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:
58 studies on the registry are indexed under Dermatitis, Seborrheic; 7 are open to participants now.
This study's enrollment of 86 is above the median of 77 across 47 interventional studies indexed under Dermatitis, Seborrheic.
Browse Dermatitis, Seborrheic studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Piroctone Olamine 0.75% Shampoo
Drug: Piroctone Olamine 0.75% Shampoo
Ketoconazole Shampoo
Drug: Ketoconazole Shampoo, 2%
Shampoo containing Piroctone Olamine 0.75%
Ketoconazole shampoo
Change in Relative Abundance of Prespecified Hair and Scalp Microbiota
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.
Time frame: Baseline, Week 2
Change in Seborrheic Dermatitis Severity Measured by the 16-Point Scale
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.
Time frame: Baseline, Week 2
Change in Scalp Skin Capacitance
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.
Time frame: Baseline, Week 2
Change in Scalp Transepidermal Water Loss
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.
Time frame: Baseline, Week 2
Change in Scalp Sebum Level
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.
Time frame: Baseline, Week 2
Change in Scalp Superoxide Dismutase (SOD) Level
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.
Time frame: Baseline, Week 2
Plan to share: No
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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