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CompletedNCT07802808Updated Sep 3, 2026

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 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

Phase
Phase 4
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
Female
01

Study 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.
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:

  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.
02

Conditions studied

  • Seborrheic Dermatitis

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Keywords

  • Seborrheic Dermatitis
  • Piroctone Olamine
  • Shampoo
  • Microbiome
03

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    Intervention

    Piroctone Olamine 0.75% Shampoo

    Drug: Piroctone Olamine 0.75% Shampoo

  • Active comparator
    Comparator (First Line Therapy)

    Ketoconazole Shampoo

    Drug: Ketoconazole Shampoo, 2%

Interventions

  • DrugPiroctone Olamine 0.75% Shampoo

    Shampoo containing Piroctone Olamine 0.75%

  • DrugKetoconazole Shampoo, 2%

    Ketoconazole shampoo

05

What researchers measure

Primary outcomes

  1. 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

  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

  3. 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

  4. 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

  5. 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

  6. 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

06

Study locations

1 site
  • dr. Cipto Mangunkusumo General Hospital
    Jakarta, 10430, Indonesia
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07802808
Lead sponsor
Indonesia University
Collaborators
PT Paragon Technology and Innovation
Responsible party
Dr. dr. Lili Legiawati, SpKK(K) (Prof. Dr. dr., Indonesia University) — Principal investigator
First posted
Sep 3, 2026
Start date
Jan 12, 2026
Primary completion
Feb 2, 2026
Completion
Feb 2, 2026
Last update
Sep 3, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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