Beyond the Scalp: A Multi-Omic Microbiome Analysis in Androgenetic Alopecia Patients at Baseline and After Oral Minoxidil Treatment Versus Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 主要终点
- Norwoord-Hamiton scale hairloss severity
研究概览
简要总结
This study is to evaluate differences in the gut and follicle/scalp microbiome signature in AGA compared to a non-AGA population. Also, to investigate differences in inflammation and other biomarkers in AGA compared to non-AGA population at baseline and after a successful treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male volunteer from 21 to 45 years old
- •Volunteer with BMI between 18.5 to 30 kg/m2
- •Volunteer willing and able to fulfill the study requirements and schedule
- •Volunteer willing to give their stool sample, as well as swabs, follicles, and blood.
- •Volunteer informed about the study objectives and procedures, and able to understand them
- •Volunteer who has given written informed consent
- •Volunteers in the healthy control panel must satisfy the following criteria:
- •Volunteer in overall good health
- •Volunteer with no diagnosis of hair loss or other condition or treatment susceptible to impact hair count and microbiome.
- •Volunteers in the AGA panel must satisfy the following criteria:
- •Volunteer diagnosed with Androgenetic Alopecia grade III Vertex to V on the Hamilton-Norwood scale
- •Volunteer willing to restrain from the use of any additional hair loss oral and topical pharmaceuticals (ex: topical minoxidil) over the course of the study
- •Volunteer eligible to undergo oral minoxidil treatment, with no contra-indication
排除标准
- •Volunteer with severe gastro-intestinal symptoms (including gluten and lactose intolerance)
- •Volunteer with auto-immune disease, diabetes; hyper or hypo-thyroidism ; chronic kidney failure
- •Volunteer with diagnosis of scalp-related disease such as folliculitis, lichen planopilaris, folliculitis decalvans, tinea capitis, head lice, or seborrheic dermatitis
- •Volunteer undergoing hypertension treatment
- •Volunteer who undertook any oral anti-hair loss pharmaceutical treatment in the past 3 months (e.g. Finasteride)
- •Volunteer who undertakes any hormone-disrupting drug
- •Volunteer who used topical minoxidil or other pharmaceutical-grade topical hair restorers in the past 3 months
- •Volunteer with a total dandruff score above 1 on the L'Oreal Dandruff scale.
- •Volunteer who used perms or hair dyes in the past 2 months
- •Volunteer who underwent scalp reduction or hair transplant procedures
- •Volunteer who declares to be deprived of freedom by administrative or legal decision
- •Volunteer who cannot be contacted by phone in case of emergency
- •Volunteer having currently participating in another clinical study
- •Volunteer who used antibiotics or antifungal medication (topical to scalp and systemic) in the past 4 weeks
- •Volunteer who used probiotics supplements in the past 4 weeks. (dietary probiotics such as yogurt, kefir, and kimchi are acceptable)
- •Volunteer who follows a non-conventional diet (e.g. vegan, ketogenic, strict intermittent fasting diets)
- •Non-inclusion Criteria:
- •Volunteer diagnosed with HIV, Hepatitis C, Hepatitis B
- •Volunteer with severe gastro-intestinal symptoms (including gluten and lactose intolerance)
- •Volunteer with auto-immune disease, diabetes; hyper or hypo-thyroidism ; chronic kidney failure
- •Volunteer with diagnosis of scalp-related disease such as folliculitis, lichen planopilaris, folliculitis decalvans, tinea capitis, head lice, or seborrheic dermatitis
- •Volunteer undergoing hypertension treatment
- •Volunteer who undertook any oral anti-hair loss pharmaceutical treatment in the past 3 months (e.g. Finasteride)
- •Volunteer who undertakes any hormone-disrupting drug
- •Volunteer who used topical minoxidil or other pharmaceutical-grade topical hair restorers in the past 3 months
- •Volunteer with a total dandruff score above 1 on the L'Oreal Dandruff scale.
- •Volunteer who used perms or hair dyes in the past 2 months
- •Volunteer who underwent scalp reduction or hair transplant procedures
- •Volunteer who declares to be deprived of freedom by administrative or legal decision
- •Volunteer who cannot be contacted by phone in case of emergency
- •Volunteer having currently participating in another clinical study
- •Volunteer who used antibiotics or antifungal medication (topical to scalp and systemic) in the past 4 weeks
- •Volunteer who used probiotics supplements in the past 4 weeks. (dietary probiotics such as yogurt, kefir, and kimchi are acceptable)
- •Volunteer who follows a non-conventional diet (e.g. vegan, ketogenic, strict intermittent fasting diets)
- •Volunteer who used anti-dandruff shampoo in the past 4 weeks (For example, commonly used brands for anti-dandruffs could be : Head & Shoulders, Sebamed, Clear, Dove, Pantene, L'OREAL, Vichy Dercos)
结局指标
主要结局
Norwoord-Hamiton scale hairloss severity
时间窗: 6 months
Scale from 1 (no hair loss) to 7 (severe hair loss)
Change in hair density
时间窗: 6 months
Change from baseline in hair density at the vertex, crown and occipital zones Unit: u/cm2
Metabolomic profiling of the stool
时间窗: 6 months
Change in concentration of metabolites in the stool of AGA vs healthy cohorts.
Gut and Scalp/Follicle Microbiome Signature Differences at Baseline
时间窗: Baseline
Taxonomic and functional composition of the gut and scalp/hair follicle microbiome. Units: relative abundance
Change in proteomic profile
时间窗: 6 months
Change in protein expression levels in scalp swabs samples, and differences between AGA and healthy cohorts.
Change in Gene Expression Profiles (Transcriptomics)
时间窗: 6 months
Evaluation of differentially expressed genes via spatial transcriptomics and single-cell RNA sequencing (scRNA-seq) from scalp biopsy samples comparing AGA participants to healthy controls. Units: Log2 Fold Change (or "Normalized Gene Expression Counts")
Metabolomic profile in blood/plasma
时间窗: 6 months
Change in concentration of metabolites in blood/plasma
Proteomic profiling of the blood
时间窗: 6 months
Change in proteins concentration levels in blood/plasma
Change in hair diameter distribution
时间窗: 6 months
Change from baseline in hair shaft diameter. Unit: µm
次要结局
- Eyebrow to hairline measurement(6 months)
- Dandruff scoring(6 months)
- Change in Subject-Reported Hair Density(6 months)
- Measurement of sebum levels(6 months)
- Gut Microbiome in Oral Minoxidil Treatment Response(6 months)
- Change in Follicular Units Distribution(6 months)