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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Aleppo, Syria
- Clinical Research Unit, Syrian Scientific Society for Medicinal Herbs, Aleppo
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
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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.
Inne nazwy:
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Inny: 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.
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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.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percent change from baseline in scalp sebum content measured by Sebumeter
Ramy czasowe: Baseline (Day 0) and Week 6
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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.
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Baseline (Day 0) and Week 6
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Hair shine score (investigator-rated)
Ramy czasowe: Baseline, Week 2, Week 4, Week 6
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Standardized 10-point scale via standardized lighting and photography.
Higher scores indicate improved shine.
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Baseline, Week 2, Week 4, Week 6
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Scalp comfort score (participant-reported)
Ramy czasowe: Baseline, Week 2, Week 4, Week 6
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Standardized 10-point scale (1=severe discomfort, 10=complete comfort).
Higher scores indicate improved comfort.
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Baseline, Week 2, Week 4, Week 6
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Investigator Global Assessment success rate
Ramy czasowe: Week 6
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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.
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Week 6
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Adverse event rate
Ramy czasowe: Throughout 6-week study period
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Number and severity of adverse events assessed via standardized query, severity grading (mild/moderate/severe), and causality assessment.
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Throughout 6-week study period
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Scalp irritation score
Ramy czasowe: Week 2, Week 4, Week 6
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Scalp irritation assessed at each visit via participant self-report with severity grading.
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Week 2, Week 4, Week 6
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Product adherence percentage
Ramy czasowe: Throughout 6-week study period
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Compliance assessed via returned product weighing (expected use: 35 g/week) and electronic diary entries.
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Throughout 6-week study period
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Treatment compliance rate
Ramy czasowe: Throughout 6-week study period
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Percentage of expected product use calculated from returned product weight.
Threshold: ≥80% compliance.
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Throughout 6-week study period
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Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Hisham M Kasem, Prof., Syrian Scientific Society for Medicinal Herbs
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SHAMNA-2024-008
- SSS-008-2024 (Identyfikator rejestru: Syrian Scientific Society for Medicinal Herbs (SHAMNA))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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Badania kliniczne na Cosmetic Management of Oily Scalp
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