An interventional study of Ozonated oil-based cosmetic emulsion and Matched vehicle control in Cosmetic Management of Oily Scalp, sponsored by Chadi Khatib. Completed at 1 site in Syria. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Chadi Khatib · Not applicable, Interventional, and Treatment
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:
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 are common among 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:
STUDY DESIGN:
Single-center, randomized, double-blind, placebo-controlled parallel-group trial conducted at the Research Unit of the Syrian Scientific Society for Medicinal Herbs (SHAMNA), Aleppo, Syria, between April and May 2024 (screening and enrollment: April 6 - May 18, 2024), under institutional authorization from Manara University Faculty of Pharmacy.
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:
The primary endpoint (percent change from baseline in Week 6 sebum) was analyzed by ANCOVA with baseline sebum as covariate, following FDA guidance on covariate adjustment. Missing Week 6 data were handled by Multiple Imputation by Chained Equations (MICE; m = 30). Continuous secondary endpoints (hair manageability, hair shine, scalp comfort) were analyzed by baseline-adjusted ANCOVA on observed cases at Week 6, with treatment group as a fixed factor and the corresponding baseline score as a continuous covariate. Binary IGA success was analyzed by logistic regression in the per-protocol population. Multiplicity was controlled by the Hochberg procedure. Seven pre-specified sensitivity analyses (observed-case, per-protocol, MNAR delta-adjustment, worst-case, extreme worst-case, best-case, and multi-covariate ANCOVA) confirmed robustness.
KEY FINDINGS:
Active treatment reduced scalp sebum by 28.5% vs. 9.8% with placebo (adjusted between-group difference: -19.0%, 95% CI: -22.2 to -15.8, p\<0.0001, ITT with MICE), exceeding the pre-specified 15% clinically meaningful threshold. All secondary endpoints favored active treatment after multiplicity adjustment.
LIMITATIONS:
Single-center, female-only, 6-week duration. Generalizability to males and long-term safety require further study.
58 studies on the registry are indexed under Dermatitis, Seborrheic; 7 are open to participants now.
This study's enrollment of 66 is below the median of 77 across 47 interventional studies indexed under Dermatitis, Seborrheic.
Browse Dermatitis, Seborrheic studies →This is the only study on the registry with Chadi Khatib as lead sponsor.
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The criteria were revised on the registry on Sep 30, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Also known as: Ozonated Oil Emulsion
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.
Also known as: Vehicle Control
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.
Time frame: Baseline (Day 0) and Week 6
Hair shine score (investigator-rated)
Standardized 10-point scale via standardized lighting and photography. Higher scores indicate improved shine.
Time frame: 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.
Time frame: 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.
Time frame: Week 6
Hair manageability score (investigator-rated)
Standardized 10-point investigator visual scale (1 = unmanageable, 10 = optimal). Higher scores indicate better hair manageability.
Time frame: Baseline, Week 2, Week 4, and Week 6
Adverse event rate
Number and severity of adverse events assessed via standardized query, severity grading (mild/moderate/severe), and causality assessment.
Time frame: Throughout 6-week study period
Scalp irritation score
Scalp irritation assessed at each visit via participant self-report with severity grading.
Time frame: Week 2, Week 4, Week 6
Product adherence percentage
Compliance assessed via returned product weighing (expected use: 35 g/week) and electronic diary entries; per-protocol threshold: ≥80% of expected use.
Time frame: Throughout 6-week study period
Plan to share: Yes — De-identified participant-level data, study protocol, SAP, data dictionary, and analytic code (SAS and R) are publicly available in Harvard Dataverse.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Available since May 2026; permanent availability with DOI
Access criteria: Open public access via the repository; no request required.
Data sharing details ↗ · doi.org
No publications or documents are linked to this record.
Ran from Apr 2024 to primary completion in May 2024, 1 month.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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