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Completed

NCT Number: NCT07559617

Ozonated Oil Emulsion for Seborrhea in 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.

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Key information

Conditions

Cosmetic Management of Oily Scalp Dermatitis Dermatitis, Seborrheic Sebaceous Gland Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Unit, Syrian Scientific Society for Medicinal Herbs, Aleppo

Aleppo, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ozonated oil-based cosmetic emulsion

Other

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.

Other names: Ozonated Oil Emulsion

Matched vehicle control

Other

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.

Other names: Vehicle Control

Primary outcomes

  1. Percent change from baseline in scalp sebum content measured by Sebumeter

    Time frame: 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.

Secondary outcomes

  1. Hair shine score (investigator-rated)

    Time frame: Baseline, Week 2, Week 4, Week 6

    Standardized 10-point scale via standardized lighting and photography. Higher scores indicate improved shine.

  2. Scalp comfort score (participant-reported)

    Time frame: Baseline, Week 2, Week 4, Week 6

    Standardized 10-point scale (1=severe discomfort, 10=complete comfort). Higher scores indicate improved comfort.

  3. Investigator Global Assessment success rate

    Time frame: 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.

Other outcomes

  1. Adverse event rate

    Time frame: Throughout 6-week study period

    Number and severity of adverse events assessed via standardized query, severity grading (mild/moderate/severe), and causality assessment.

  2. Scalp irritation score

    Time frame: Week 2, Week 4, Week 6

    Scalp irritation assessed at each visit via participant self-report with severity grading.

  3. Product adherence percentage

    Time frame: Throughout 6-week study period

    Compliance assessed via returned product weighing (expected use: 35 g/week) and electronic diary entries.

  4. Treatment compliance rate

    Time frame: Throughout 6-week study period

    Percentage of expected product use calculated from returned product weight. Threshold: ≥80% compliance.

Sponsors and collaborators

Lead sponsor

Chadi Khatib

Other

Registry information

Official study title

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

Acronym: OOSE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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