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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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:
- 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 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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Aleppo, Siria
- Research Unit, Syrian Scientific Society for Medicinal Herbs, Aleppo
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Female sex (biological), ages 18-40 years.
- Objective sebum measurement ≥200 µg/cm² at screening (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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
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.
Otros nombres:
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Otro: 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. |
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percent change from baseline in scalp sebum content measured by Sebumeter
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hair shine score (investigator-rated)
Periodo de tiempo: 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
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Scalp comfort score (participant-reported)
Periodo de tiempo: 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. |
Baseline, Week 2, Week 4, Week 6
|
|
Investigator Global Assessment success rate
Periodo de tiempo: 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
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Hair manageability score (investigator-rated)
Periodo de tiempo: Baseline, Week 2, Week 4, and Week 6
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Standardized 10-point investigator visual scale (1 = unmanageable, 10 = optimal). Higher scores indicate better hair manageability. |
Baseline, Week 2, Week 4, and Week 6
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adverse event rate
Periodo de tiempo: 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. |
Throughout 6-week study period
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Scalp irritation score
Periodo de tiempo: 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
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Product adherence percentage
Periodo de tiempo: Throughout 6-week study period
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Compliance assessed via returned product weighing (expected use: 35 g/week) and electronic diary entries; per-protocol threshold: ≥80% of expected use. |
Throughout 6-week study period
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Hisham M Kasem, Prof., Syrian Scientific Society for Medicinal Herbs and Complementary Medicine (SHAMNA)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SHAMNA-2024-008
- SHAMNA-008-2024 (Identificador de registro: Syrian Scientific Society for Medicinal Herbs and Complementary Medicine (SHAMNA))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
De-identified participant-level data, study protocol, SAP, data dictionary, and analytic code (SAS and R) are publicly available in Harvard Dataverse.
Marco de tiempo para compartir IPD
Available since May 2026; permanent availability with DOI
Criterios de acceso compartido de IPD
Open public access via the repository; no request required.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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