Seborrheic DermatitisPhase 4NCT07802808
Effect of 0.75% Piroctone Olamine Shampoo on the Hair and Scalp Microbiota of Hijab-Wearing Women With Seborrheic Dermatitis in Indonesia
A Phase 4 study of Seborrheic Dermatitis, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women only
- Conditions the study is for
- Seborrheic Dermatitis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Jan 2026to 2 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Seborrheic Dermatitis
- Being tested
- Piroctone Olamine 0.75% Shampoo, Ketoconazole Shampoo, 2%
- Keywords
- Seborrheic Dermatitis, Piroctone Olamine, Shampoo, Microbiome
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piroctone Olamine 0.75% ShampooDrug
Shampoo containing Piroctone Olamine 0.75%
Ketoconazole Shampoo, 2%Drug
Ketoconazole shampoo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Piroctone Olamine 0.75% Shampoo Receives: Drug: Piroctone Olamine 0.75% Shampoo |
| Comparator (First Line Therapy) | Active comparator | Ketoconazole Shampoo Receives: Drug: Ketoconazole Shampoo, 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start12 Jan 2026
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seborrheic DermatitisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- PT Paragon Technology and Innovation
- Responsible party
- Principal investigator, Dr. dr. Lili Legiawati, SpKK(K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802808
- Sponsor's protocol ID
- KET459UN2F1ETIKPPM00022025
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07802808
- Acronym / sponsor ID
- KET459UN2F1ETIKPPM00022025
- Conditions
- Seborrheic Dermatitis
- Keywords
- Seborrheic Dermatitis, Piroctone Olamine, Shampoo, Microbiome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- PT Paragon Technology and Innovation
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Piroctone Olamine 0.75% ShampooPiroctone Olamine 0.75% Shampoo |
| Comparator (First Line Therapy) | Active comparator | Drug: Ketoconazole Shampoo, 2%Ketoconazole Shampoo |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piroctone Olamine 0.75% ShampooShampoo containing Piroctone Olamine 0.75% | Drug | Intervention |
| Ketoconazole Shampoo, 2%Ketoconazole shampoo | Drug | Comparator (First Line Therapy) |
Primary outcome
Change in Relative Abundance of Prespecified Hair and Scalp Microbiota
Time frame: 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.
Change in Seborrheic Dermatitis Severity Measured by the 16-Point Scale
Time frame: 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.
Change in Scalp Skin Capacitance
Time frame: 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.
Change in Scalp Transepidermal Water Loss
Time frame: 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.
Change in Scalp Sebum Level
Time frame: 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.
Change in Scalp Superoxide Dismutase (SOD) Level
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Seborrheic Dermatitis, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Relative Abundance of Prespecified Hair and Scalp Microbiota (time frame: Baseline, Week 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.