Ozonated Oil Emulsion for Seborrhea in Women (OOSE)

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.

Study Overview

• Status: Completed
• Conditions: Cosmetic Management of Oily Scalp
• Intervention / Treatment: Other: Ozonated oil-based cosmetic emulsion; Other: Matched vehicle control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other Names: Ozonated Oil Emulsion
Other: 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.	Other: 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.; Other Names: Vehicle Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change from baseline in scalp sebum content measured by Sebumeter	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair shine score (investigator-rated)	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)	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event rate	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	Scalp irritation assessed at each visit via participant self-report with severity grading.	Week 2, Week 4, Week 6
Product adherence percentage	Compliance assessed via returned product weighing (expected use: 35 g/week) and electronic diary entries.	Throughout 6-week study period
Treatment compliance rate	Percentage of expected product use calculated from returned product weight. Threshold: ≥80% compliance.	Throughout 6-week study period

Collaborators and Investigators

• Sponsor: Chadi Khatib
• Investigators: Study Chair: Hisham M Kasem, Prof., Syrian Scientific Society for Medicinal Herbs

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2024
• Primary Completion (Actual): May 18, 2024
• Study Completion (Actual): May 18, 2024

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cosmetic dermatology; Biotin; Ozonated oils; Oily scalp; Seborrhea; Sebum reduction
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin Diseases, Eczematous; Sebaceous Gland Diseases; Dermatitis; Skin and Connective Tissue Diseases; Dermatitis, Seborrheic
• Other Study ID Numbers: SHAMNA-2024-008; SSS-008-2024 (Registry Identifier: Syrian Scientific Society for Medicinal Herbs (SHAMNA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: Start Date: Within 6 months of publication End Date: Permanent availability with DOI
• IPD Sharing Access Criteria: 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 Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No