Effect of 0.75% Piroctone Olamine Shampoo on the Hair and Scalp Microbiota of Hijab-Wearing Women With Seborrheic Dermatitis in Indonesia
2026年8月31日 更新者：Dr. dr. Lili Legiawati, SpKK(K)、Indonesia University
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?
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
86
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Jakarta、インドネシア、10430
- dr. Cipto Mangunkusumo General Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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:
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention
Piroctone Olamine 0.75% Shampoo
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Shampoo containing Piroctone Olamine 0.75%
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アクティブコンパレータ：Comparator (First Line Therapy)
Ketoconazole Shampoo
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Ketoconazole shampoo
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Relative Abundance of Prespecified Hair and Scalp Microbiota
時間枠：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.
|
Baseline, Week 2
|
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Change in Seborrheic Dermatitis Severity Measured by the 16-Point Scale
時間枠：Baseline, Week 2
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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
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Change in Scalp Skin Capacitance
時間枠：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.
|
Baseline, Week 2
|
|
Change in Scalp Transepidermal Water Loss
時間枠：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.
|
Baseline, Week 2
|
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Change in Scalp Sebum Level
時間枠：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.
|
Baseline, Week 2
|
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Change in Scalp Superoxide Dismutase (SOD) Level
時間枠：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.
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Baseline, Week 2
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年1月12日
一次修了 (実際)
2026年2月2日
研究の完了 (実際)
2026年2月2日
試験登録日
最初に提出
2026年8月31日
QC基準を満たした最初の提出物
2026年8月31日
最初の投稿 (実際)
2026年9月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月3日
QC基準を満たした最後の更新が送信されました
2026年8月31日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- KET459UN2F1ETIKPPM00022025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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