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.

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.

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

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.

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

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.

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.