For an Investigator-led Hair Study Comparing Between Healthy and Hair Loss Volunteers

Официальное название

Beyond the Scalp: A Multi-Omic Microbiome Analysis in Androgenetic Alopecia Patients at Baseline and After Oral Minoxidil Treatment Versus Healthy Controls

Обзор

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

Первичные конечные точки

• Norwoord-Hamiton scale hairloss severity [Срок оценки: 6 months]
• Change in hair density [Срок оценки: 6 months]
• Metabolomic profiling of the stool [Срок оценки: 6 months]
• Gut and Scalp/Follicle Microbiome Signature Differences at Baseline [Срок оценки: Baseline]
• Change in proteomic profile [Срок оценки: 6 months]
• Change in Gene Expression Profiles (Transcriptomics) [Срок оценки: 6 months]
• Metabolomic profile in blood/plasma [Срок оценки: 6 months]
• Proteomic profiling of the blood [Срок оценки: 6 months]
• Change in hair diameter distribution [Срок оценки: 6 months]

Вторичные конечные точки (6)

• Eyebrow to hairline measurement [Срок оценки: 6 months]
• Dandruff scoring [Срок оценки: 6 months]
• Change in Subject-Reported Hair Density [Срок оценки: 6 months]
• Measurement of sebum levels [Срок оценки: 6 months]
• Gut Microbiome in Oral Minoxidil Treatment Response [Срок оценки: 6 months]
• Change in Follicular Units Distribution [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07716748 · 2024-3681

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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