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Ozonated Oil Emulsion for Seborrhea in Women (OOSE)

2026年4月24日 更新者：Chadi Khatib

A Randomized, Double-Blind, Placebo-Controlled Trial of an Ozonated Oil-Based Emulsion With Biotin for Seborrhea Management: Chemical Characterization, Stability Profiling, and Clinical Efficacy in Adult Women

This study evaluates a new ozonated oil-based hair cream for women with oily scalp (seborrhea). The cream contains natural oils (moringa, wheat germ, olive, and chili extract) treated with ozone, plus biotin (vitamin B7).

66 women aged 18-40 years participated in this 6-week study. Participants were randomly assigned to receive either:

  • The active cream (ozonated oils + biotin), OR
  • A placebo cream (without active ingredients)

Neither the participants nor the researchers knew which cream was given (double-blind). Participants applied the cream to their scalp every evening for 6 weeks.

The main goal was to measure changes in scalp oil (sebum) production at Week 6 compared to baseline. Other outcomes included hair manageability, shine, and scalp comfort.

Results showed that the active cream significantly reduced scalp oil by 28% compared to 10% in the placebo group. The cream was well-tolerated with only mild side effects (scalp irritation in 6% of active group).

This study suggests that ozonated oil emulsion may be a safe and effective cosmetic option for managing oily scalp in women.

研究概览

地位

完全的

条件

干预/治疗

详细说明

BACKGROUND:

Seborrheic scalp conditions affect 3-5% of adults, causing excessive oiliness and social discomfort. Current treatments use synthetic surfactants that may damage hair and scalp barrier. Ozonated oils represent a "green chemistry" approach that modifies natural oils to create bioactive compounds with antimicrobial and sebum-regulating properties.

INTERVENTION:

The study product is a low oil-in-water emulsion containing:

  • Ozonated oil blend (7%): Moringa oleifera, Triticum vulgare, Olea europaea, Capsicum annuum oleoresin
  • Biotin (0.1%): Vitamin B7 for keratin synthesis
  • Placebo: Identical base without ozonated oils and biotin

STUDY DESIGN:

Single-center, randomized, double-blind, placebo-controlled parallel-group trial conducted at Al-Manara University, Syria (February-May 2024).

PARTICIPANTS:

66 adult women (18-40 years) with objective sebum ≥200 μg/cm² and self-reported daily hair washing due to oily scalp. Female-only enrollment to minimize sex-based variability in sebum production.

PRIMARY ENDPOINT:

Percent change from baseline in sebumeter-measured scalp sebum content at Week 6.

SECONDARY ENDPOINTS:

Hair manageability, shine, scalp comfort (0-10 scales), and Investigator Global Assessment.

STATISTICAL ANALYSIS:

ANCOVA on Week 6 absolute values with baseline covariate, following FDA guidance on covariate adjustment. Sensitivity analyses included MMRM and per-protocol.

KEY FINDINGS:

Active treatment showed 28.5% sebum reduction vs. 9.8% placebo (difference:

-18.7%, 95% CI: -22.0 to -15.5, p<0.0001), exceeding the 15% clinically meaningful threshold. All secondary endpoints favored active treatment.

LIMITATIONS:

Single-center, female-only, 6-week duration. Generalizability to males and long-term safety require further study.

研究类型

介入性

注册 (实际的)

66

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 叙利亚
      • Aleppo、叙利亚
        • Clinical Research Unit, Syrian Scientific Society for Medicinal Herbs, Aleppo

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Female sex (biological), ages 18-40 years
  • Objective sebum measurement ≥200 µg/cm² at baseline (Sebumeter SM 815)
  • Self-reported daily or near-daily hair washing due to oily scalp
  • Willing to abstain from other hair treatments for 2-week washout and study duration
  • Signed informed consent

Exclusion Criteria:

  • Active scalp dermatoses (psoriasis, atopic dermatitis, tinea capitis) requiring medical treatment
  • Known hypersensitivity to study ingredients or fragrance components
  • Pregnancy, lactation, or planned pregnancy during study period
  • Systemic medications affecting sebum production (isotretinoin, hormonal contraceptives initiated within 3 months, anti-androgens)
  • Participation in other cosmetic or pharmaceutical trials within 30 days

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Ozonated oil-based cosmetic emulsion
Low oil-in-water emulsion containing ozonated natural oils (Moringa oleifera, Triticum vulgare, Olea europaea, Capsicum annuum oleoresin) plus biotin 0.1%. Applied 5g to scalp evening, overnight, rinsed morning for 6 weeks.
其他：Ozonated oil-based cosmetic emulsion
Low oil-in-water emulsion containing ozonated natural oils (Moringa oleifera 3%, Triticum vulgare 1.95%, Olea europaea 2%, Capsicum annuum oleoresin 0.05%) plus biotin 0.1%. Applied 5g to scalp evening, overnight, rinsed morning for 6 weeks.
其他名称：
  • Ozonated Oil Emulsion
其他：Matched vehicle control
Identical base formulation with caprylic/capric triglyceride and isopropyl palmitate to match total oil phase (8%), rheology, and cosmetic elegance. Same application protocol: 5g evening, overnight, 6 weeks.
其他：Matched vehicle control
Identical base formulation with caprylic/capric triglyceride 6% and isopropyl palmitate 2% to match total oil phase (8%), rheology, and cosmetic elegance. Same application protocol: 5g evening, overnight, 6 weeks.
其他名称：
  • 车辆控制

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percent change from baseline in scalp sebum content measured by Sebumeter
大体时间：Baseline (Day 0) and Week 6
Objective measurement of scalp sebum production using Sebumeter SM 815 (Courage+Khazaka, Germany). Three standardized sites (vertex, left and right parietal regions) measured and averaged. Negative values indicate sebum reduction. Pre-specified clinically meaningful threshold: 15% absolute reduction.
Baseline (Day 0) and Week 6

次要结果测量

结果测量
措施说明
大体时间
Hair shine score (investigator-rated)
大体时间：Baseline, Week 2, Week 4, Week 6
Standardized 10-point scale via standardized lighting and photography. Higher scores indicate improved shine.
Baseline, Week 2, Week 4, Week 6
Scalp comfort score (participant-reported)
大体时间：Baseline, Week 2, Week 4, Week 6
Standardized 10-point scale (1=severe discomfort, 10=complete comfort). Higher scores indicate improved comfort.
Baseline, Week 2, Week 4, Week 6
Investigator Global Assessment success rate
大体时间：Week 6
5-point categorical scale dichotomized as success (clear/almost clear) versus failure (mild/moderate/severe). Assessed in per-protocol population with complete Week 6 data.
Week 6

其他结果措施

结果测量
措施说明
大体时间
Adverse event rate
大体时间：Throughout 6-week study period
Number and severity of adverse events assessed via standardized query, severity grading (mild/moderate/severe), and causality assessment.
Throughout 6-week study period
Scalp irritation score
大体时间：Week 2, Week 4, Week 6
Scalp irritation assessed at each visit via participant self-report with severity grading.
Week 2, Week 4, Week 6
Product adherence percentage
大体时间：Throughout 6-week study period
Compliance assessed via returned product weighing (expected use: 35 g/week) and electronic diary entries.
Throughout 6-week study period
Treatment compliance rate
大体时间：Throughout 6-week study period
Percentage of expected product use calculated from returned product weight. Threshold: ≥80% compliance.
Throughout 6-week study period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chadi Khatib

调查人员

  • 学习椅：Hisham M Kasem, Prof.、Syrian Scientific Society for Medicinal Herbs

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年4月6日

初级完成 (实际的)

2024年5月18日

研究完成 (实际的)

2024年5月18日

研究注册日期

首次提交

2026年4月16日

首先提交符合 QC 标准的

2026年4月24日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年4月30日

上次提交的符合 QC 标准的更新

2026年4月24日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SHAMNA-2024-008
  • SSS-008-2024 (注册表标识符：Syrian Scientific Society for Medicinal Herbs (SHAMNA))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified participant data, statistical analysis plan, and study protocol will be made available through an established public repository (e.g., Harvard Dataverse, Zenodo, or equivalent) upon publication. Repository selection will be finalized based on technical compatibility and accessibility at the time of data deposit.

IPD 共享时间框架

Start Date: Within 6 months of publication End Date: Permanent availability with DOI

IPD 共享访问标准

Who: Qualified researchers with methodologically sound proposals What: De-identified participant data (CSV), statistical analysis plan (PDF), study protocol (PDF), and analytic code (SAS/R scripts) How: Submit request via repository platform with brief research proposal. Data use agreement required. Contact corresponding author for access procedures.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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