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

NCT07802808 | Completed Phase 4 DMC

• 1 other identifier: KET459UN2F1ETIKPPM00022025
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does piroctone olamine shampoo improve the signs and symptoms of seborrheic dermatitis?
2. 2.Does piroctone olamine shampoo cause any scalp or hair-related side effects?
3. 3.Attend screening and study visits for scalp and hair examinations.
4. 4.Use either piroctone olamine shampoo or ketoconazole shampoo as instructed during the study.
5. 5.Provide hair and scalp samples for microbiota testing and superoxide dismutase testing.
6. 6.Have scalp hydration, water loss, and sebum levels measured.
7. 7.Report any discomfort, scalp irritation, or other side effects during the study.

Conditions

Seborrheic Dermatitis

Keywords

Seborrheic Dermatitis; Piroctone Olamine; Shampoo; Microbiome

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Baseline, Week 2

Study Arms (2)

Intervention

EXPERIMENTAL

Piroctone Olamine 0.75% Shampoo

Drug: Piroctone Olamine 0.75% Shampoo

Comparator (First Line Therapy)

ACTIVE COMPARATOR

Ketoconazole Shampoo

Drug: Ketoconazole Shampoo, 2%

Interventions

Ketoconazole Shampoo, 2% DRUG

Ketoconazole shampoo

Comparator (First Line Therapy)

Piroctone Olamine 0.75% Shampoo DRUG

Shampoo containing Piroctone Olamine 0.75%

Intervention

Eligibility Criteria

• Age: 18 Years - 59 Years
• Gender Eligibility Details: Hijab-wearing Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead
• PT Paragon Technology and Innovation: collaborator

Study Sites (1)

dr. Cipto Mangunkusumo General Hospital

Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Dermatitis, Seborrheic

Interventions

piroctone olamine

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. dr.

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: January 12, 2026
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)