Skip to content

Ozonated Oil Emulsion for Seborrhea in Women

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07559617
Acronym
OOSE
Enrollment
66
Registered
2026-04-30
Start date
2024-04-06
Completion date
2024-05-18
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cosmetic Management of Oily Scalp

Keywords

Ozonated oils, Biotin, Oily scalp, Seborrhea, Cosmetic dermatology, Sebum reduction

Brief summary

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.

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.

Interventions

OTHEROzonated 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.

OTHERMatched 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.

Sponsors

Chadi Khatib
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Triple-blind design: participants, investigators, study staff, and statisticians remained masked to treatment assignment throughout the trial. Product identity concealed via identical packaging, appearance, texture, and fragrance-masking.

Intervention model description

Double-blind, randomized, placebo-controlled, parallel-group trial with 1:1 allocation ratio and stratification by baseline sebum severity

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percent change from baseline in scalp sebum content measured by SebumeterBaseline (Day 0) and Week 6Objective 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

MeasureTime frameDescription
Hair shine score (investigator-rated)Baseline, Week 2, Week 4, Week 6Standardized 10-point scale via standardized lighting and photography. Higher scores indicate improved shine.
Scalp comfort score (participant-reported)Baseline, Week 2, Week 4, Week 6Standardized 10-point scale (1=severe discomfort, 10=complete comfort). Higher scores indicate improved comfort.
Investigator Global Assessment success rateWeek 65-point categorical scale dichotomized as success (clear/almost clear) versus failure (mild/moderate/severe). Assessed in per-protocol population with complete Week 6 data.

Countries

Syria

Contacts

STUDY_CHAIRHisham M Kasem, Prof.

Syrian Scientific Society for Medicinal Herbs

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026