Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Ozonated Oil Emulsion for Seborrhea in Women (OOSE)

24 april 2026 bijgewerkt door: Chadi Khatib

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

66

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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.
Andere namen:
  • Ozonated Oil Emulsion
Ander: 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.
Ander: 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.
Andere namen:
  • Voertuig Controle

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent change from baseline in scalp sebum content measured by Sebumeter
Tijdsspanne: 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.
Baseline (Day 0) and Week 6

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hair shine score (investigator-rated)
Tijdsspanne: Baseline, Week 2, Week 4, Week 6
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)
Tijdsspanne: Baseline, Week 2, Week 4, Week 6
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
Tijdsspanne: 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.
Week 6

Andere uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chadi Khatib

Onderzoekers

  • Studie stoel: Hisham M Kasem, Prof., Syrian Scientific Society for Medicinal Herbs

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 april 2024

Primaire voltooiing (Werkelijk)

18 mei 2024

Studie voltooiing (Werkelijk)

18 mei 2024

Studieregistratiedata

Eerst ingediend

16 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 april 2026

Eerst geplaatst (Werkelijk)

30 april 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 april 2026

Laatste update ingediend die voldeed aan QC-criteria

24 april 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SHAMNA-2024-008
  • SSS-008-2024 (Register-ID: Syrian Scientific Society for Medicinal Herbs (SHAMNA))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Ozonated oil-based cosmetic emulsion

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Papua New Guinea

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

Abonneren