CTRI/2023/07/055579已完成不适用
Scalp Ecosystem Investigation on Asian Volunteers with Dandruff Compared to Volunteers without Dandruff
Singapore Centre for Environmental Life Sciences Engineering1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年4月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To investigate the presence of biofilms, microbiome composition, microbial
研究概览
简要总结
- To investigate the presence of biofilms, microbiome composition, microbial metabolites, and oxidative stress indicators on scalp and hair follicle, and measure hair fibre properties by comparing volunteers with dandruff versus volunteers without dandruff through microbiome, metabolites and visualisation evaluations.
- To identify immunological and differentiation changes in hair follicles by follicular unit extraction (FUE)
- To compare scalp characteristics between volunteers with dandruff versus volunteers without dandruff through instrumental evaluation, clinical grading and imaging.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male or female volunteer from 18 to 45 years old.
- •2.Asian population with skin type II-V per Fitzpatrick classification.
- •3.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.
- •4.Female of childbearing potential willing to undergo urine pregnancy test.
- •5.For dandruff volunteers: a.
- •Adherent dandruff score greater than 1.5(Loreal Dandruff Scale) b.
- •No limit for non-adherent dandruff score (Loreal Dandruff Scale).
- •6.For volunteer without dandruff: score 0 on each quadrant of scalp (Loreal Dandruff Scale).
- •7.Volunteer informed about the study objectives and procedures, and able to understand them, willing to fulfil the requirement and schedule.
- •8.Volunteer willing to give written informed consent and willing to comply with the study protocol and schedule.
- •9.Subject willing to use neutral shampoo for 3 weeks.Do not apply any cosmetics (gels, mousse, sprays, topical lotions, dyes, creams moisturising products or shampoo) on the scalp during 3-week wash out phase and 3 days before visit.Do not wet the hair (no swimming, aquatic sports, massages etc.) 3 days before testing visit.Do not comb their hair on the morning of the testing visit.
- •10.Absence of diagnosed skin-related condition (excluding seborrheic dermatitis).
- •11.With natural hair and hair length greater than and equal to 8cm.
- •Willing to have swab sampling (2 X 2cm2, 2 areas) with hair parted on severest dandruff zone.
- •Willing to have 100 hairs cut on the scalp (on severest dandruff zone).
- •Willing to have one scalp biopsy (3mm in diameter) and one Follicle Unit Extraction (FUE 1.0 mm in diameter) collection on scalp.
- •Agree to take a COVID-19 RT-PCR test on neutral shampoo application visit.
排除标准
- •Volunteer who has BMI>
- •Volunteer with any medical or surgical record or scalp disease which in the opinion of the investigator might harm the volunteer or interfere with the present study.
- •Bald volunteer or without hair on top (equivalent to androgenic alopecia stage IV or more under the Hamilton classification amended by Norwood; NORWOOD OT.
- •Male pattern baldness.
- •Classification and incidence.
- •South Med J, 1975, 68: 1359- 1365) for male, and hair loss symptom above I-2 with Ludwig scale for female.
- •Female volunteer who is known to be pregnant or who is intending to become pregnant over the duration of the study.
- •Female volunteer who is currently breast-feeding or has been breast-feeding in the 6 months prior to the start of 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 used within the month before inclusion or plan to use during the study any systemic medications that can influence dandruff (e.g. antibiotics, steroidal and non-steroidal anti-inflammatory drugs, corticoids,) or which in the opinion of the principal investigator can influence the study.
- •Volunteer who has taken a retinoid within the past 6 months and/or intend to take it during the study period.
- •Volunteer who has used a topical corticosteroid or a topical antifungal medicinal product locally on the face and scalp during the two weeks prior to the start of the study and/or intend to use it during the study period.
- •Volunteer who has skin marks on the scalp that could interfere with the assessments (e.g. pigmentation, tattoo, scarring etc.)
- •Volunteer who has used products for the scalp (dyeing, bleaching etc.) within the 3 weeks prior to the study and/or intend to use it during the study period.
- •Volunteer who has used cosmetic anti-hair loss treatment (systemic or topical) during the last three months before the start of the study, or/and volunteer who has used medical anti-hair loss treatment (systemic or topical, ex: minoxidil, finasteride, etc.) during the last six months before the start of the study and/or intend to use it during the study period.
- •Volunteers with an immunocompromised state or infectious diseases like HIV, Cancer, Diabetes, Hepatitis, Syphilis, Herpes, etc.
- •which in the opinion of the investigator can influence the study assessments and procedures.
- •Volunteer regularly engaging in aquatic or nautical sports and/or regularly having saunas.
- •Volunteer who has been excessively exposed to sun or UV during the past month (at the discretion of the investigator).
- •Volunteer with a history of cardiovascular or circulatory problems.
- •Volunteer who has taken part in a clinical trial, the exclusion period for which is not over or currently participating in another clinical trial.
- •Volunteer deprived of their liberty by a court or administrative ruling.
- •Having used other medication which in the opinion of the investigator might harm the volunteer or interfere with the present study.
- •Volunteer who cannot be contacted by phone in case of emergency.
- •Volunteer belonging to the staff of the investigating centre.
结局指标
主要结局
To investigate the presence of biofilms, microbiome composition, microbial
时间窗: Visit 1(D-21) | Visit 2(D-3) | Visit 3(D0)
metabolites, & oxidative stress indicators on scalp and hair follicle, and measure hair fibre properties by comparing volunteers with dandruff versus volunteers without dandruff through microbiome, metabolites and visualisation evaluations.
时间窗: Visit 1(D-21) | Visit 2(D-3) | Visit 3(D0)
次要结局
- -To identify immunological & differentiation changes in hair follicles by follicular unit extraction (FUE).(-To compare scalp characteristics between volunteers with dandruff versus volunteers without dandruff through instrumental evaluation, clinical grading)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effects on the Scalp Microbiota of a 1% Selenium Disulfide and 1% Salicylic Acid Shampoo After 2% Ketaconazole Foaming Gel Treatment for Scalp Seborrheic DermatitisScalp DermatitisDermatitisNCT04057950L'Oreal80
尚未招募
不适用
Fecal Transplant for Alopecia AreataAlopecia AreataNCT04833179Tel-Aviv Sourasky Medical Center110
已完成
不适用
Isolation and Characterization of Multiple Microbial Species From Diverse Healthy AdultsHuman MicrobiomeNCT05150184Danisco52
尚未招募
早期 1 期
Characterization of the Microbiome in Cutaneous T Cell Lymphoma Skin Lesions Before and After Use of APR-TD011® (RLF-TD011®) Spray SolutionCutaneous T Cell LymphomaNCT05728879Northwestern University30
已完成
4 期
Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus ColonizationHuman MicrobiomeNCT04222699VA Office of Research and Development58