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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Aleppo, Síria
- Clinical Research Unit, Syrian Scientific Society for Medicinal Herbs, Aleppo
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
Outros nomes:
|
|
Outro: 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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percent change from baseline in scalp sebum content measured by Sebumeter
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hair shine score (investigator-rated)
Prazo: 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)
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adverse event rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Throughout 6-week study period
|
Percentage of expected product use calculated from returned product weight.
Threshold: ≥80% compliance.
|
Throughout 6-week study period
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Hisham M Kasem, Prof., Syrian Scientific Society for Medicinal Herbs
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SHAMNA-2024-008
- SSS-008-2024 (Identificador de registro: Syrian Scientific Society for Medicinal Herbs (SHAMNA))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .