NCT07805031进行中（未招募）不适用
Decoding the Biological Mechanisms of Itchy Scalp
L'Oreal1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2025年4月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- High-coverage targeted lipidomics
研究概览
简要总结
This is a single-center, cross-sectional, observational clinical study to investigate the clinical attributes and lipidomic signatures of itchy scalp with and without dandruff, aiming to validate the biological distinctiveness of pure scalp pruritus. A total of 132 female participants were enrolled and allocated to three cohorts (44 participants each) based on scalp pruritus and dandruff status. Clinical scoring, instrumental biophysical measurements, self-assessment questionnaires, and lipidomic signatures were analyzed and compared across groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female volunteer from 18 to 50 years old, in good general health (physical, mental, and social well-being) according to volunteer self-declaration and investigator's opinion.
- •Female of childbearing potential who is not sexually active, or who is using an effective contraceptive method for at least one month before the beginning of the study and throughout the study.
- •Female of childbearing potential willing to undergo urine pregnancy test.
- •Volunteer has the life habit of washing hair twice to 7 times every week.
- •Volunteer has scalp conditions based on group:
- •a. Group 1 i. Self-declared normal scalp without pruritus, score=0 on pruritus Visual Analog Scale (VAS).
- •ii. Adherent dandruff score ≤0.5 based on Dandruff Photographic Scales (DFS) assessed by dermatologist.
- •b. Group 2 i. Scalp pruritus score ≥4 and ≤8 on pruritus VAS. ii. Adherent dandruff score ≥2 and ≤4 based on DFS assessed by dermatologist. c. Group 3 i. Scalp pruritus score ≥4 and ≤8 on pruritus VAS. ii. Adherent dandruff score ≤0.5 based on DFS assessed by dermatologist.
- •Volunteer with Asian scalp.
- •Volunteer living in Shanghai for at least one year.
- •Volunteer willing and able to fulfil the study requirements and schedule.
- •Volunteer informed about the study objectives and procedures, and able to understand them.
- •Volunteer who has given written informed consent.
排除标准
- •Volunteer who is pregnant or lactating or who is planning to become pregnant during the study.
- •Menopausal female (with absence of menstruations for less than one year) or post-menopausal female (with absence of menstruations for more than one year).
- •Volunteer who has hair treatments including hair coloration, bleaching or perm within 3 months before inclusion.
- •Volunteer who has skin cancer, severe autoimmune skin diseases or other moderate or severe skin diseases.
- •Volunteer who has Seborrheic dermatitis, psoriasis, scalp pityriasis, tinea capitis, atopic dermatitis, folliculitis, alopecia or other skin disorders might interfere the assessment on scalp or calves determined by the dermatologist.
- •Volunteer who has diagnosed endocrine disorders (e.g. hypopituitarism, diabetes mellitus, polycystic ovary syndrome), auto-immune medical conditions (e.g. systemic lupus erythematosus (SLE) and Rheumatoid arthritis (RA)), hyper- or hypothyroidism, hypertension or mental illness (e.g. diagnosed depression, schizophrenia, trichotillomania).
- •Volunteer who has active gastrointestinal (GI) bleeding or history of heart or vascular disease.
- •Volunteer who has systemic medication (e.g. steroidal and non-steroidal anti-inflammatory drugs, corticoids, insulin, antihistamines, hormones, antihypertensive, antibiotics such as quinolone, tetracycline, thiazides, fluoroquinolones) within one month before inclusion.
- •Volunteer who has topical treatments of prescription, over-the-counter remedies (e.g. minoxidil, ketoconazole, selenium sulfide lotion) on scalp within 2 months before inclusion.
- •Volunteer who changed her routine shampoo within 2 weeks before inclusion.
- •Volunteer who has conditions considered by the Investigator as sound reasons for disqualification from enrolment into the study, because it might put the individual at significant risk, confound study results or interfere with the individual's participation.
- •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 participated within 30 days before inclusion or currently participating in another clinical study.
研究组 & 干预措施
Group 3: Pure itchy scalp (without dandruff)
Volunteers with scalp pruritus (Pruritus VAS 4-8) and no/minimal dandruff (Dandruff Score ≤ 0.5).
Group 1: Health control
Healthy volunteers with normal scalp (Pruritus VAS = 0, Adherent Dandruff Score ≤ 0.5).
Group 2: Itchy Scalp with Dandruff
Volunteers with scalp pruritus (Pruritus VAS 4-8) and adherent dandruff (Dandruff Score 2-4).
结局指标
主要结局
High-coverage targeted lipidomics
时间窗: Day 1 (Single assessment at baseline)
Targeted lipidomics using membrane filter samples on scalp
次要结局
- Clinical scalp scoring(Day 1 (Single assessment at baseline))
- Transepidermal Water Loss (TEWL)(Day 1 (Single assessment at baseline))
- Scalp hydration(Day 1 (Single assessment at baseline))
- Scalp sebum level(Day 1 (Single assessment at baseline))
- Scalp surface pH(Day 1 (Single assessment at baseline))
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
A randomized double arm comparative study on vamana karma at two different purvahna kala followed by pratimarsha nasya in participants with darunaka (pityriasis captitis)CTRI/2026/02/104965Dr Sanjota Shirashyad40
尚未招募
2 期
Homoeopathy in Alopecia AreataCTRI/2024/04/065613Rajkot Homoeopathic Medical College50
尚未招募
不适用
Consumer perception for Almond hair oilCTRI/2025/09/095346Quest Retails private Limited30
已完成
不适用
Validation of Assessment Methods of Scalp Dandruff in Adult Subjects: Correlating Adherent Scalp Flaking Score and Phototrichogram AnalysisCTRI/2024/05/067755NovoBliss Research Private Limited12
尚未招募
不适用
A study to assess the microbiome on the scalp and skin based on the dandruff and environmental factors.CTRI/2025/02/080015MS Clinical Research Pvt Ltd60