CTRI/2024/02/062767招募中不适用
A Mono-center, matched-Control Study to Investigate the Skin Biofilm Profile on Asian Acne Volunteers Compared to Healthy Volunteers.
SCELSE1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年2月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- To visualize and characterize the presence of skin microbiota as biofilm on healthy and acneic skin
研究概览
简要总结
To visualize and characterize the presence of skin microbiota as biofilm on healthy and acneic skin using biopsy samples of the back.To identify acne/phylotype-specific transformations in the immune microenvironments using biopsy samples of the back from healthy and acneic volunteers. To detect microbial species and phylotypes within the back biopsy from healthy and acneic volunteers. To isolate and collect the skin microbes for construction of in vitro skin biofilm models. To profile the skin microbiome diversity of healthy and acne skin (face and back) using whole metagenome sequencing
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Healthy non-pregnant female volunteer from 18 to 25 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 Acne subjects a.
- •Acne grading (IGA:3 moderate) on face and back declaring persistent acne since the adolescence.
- •Subjects showing the facial acne at least 15 inflammatory lesions (papules and pustules) and 25 non-inflammatory lesions (blackheads and whiteheads) on the face and the same count criteria on the upper back for acne volunteers.6.For Healthy subject: Healthy volunteer without acne on face or back in her life.7.Subject informed about the study objectives and procedures, and able to understand them.
- •8.Subject willing to give written informed consent and willing to comply with the study protocol and schedule.9.Subject willing to shower only with water 2 days before, and not shower 1 day before and not apply any topical hygiene/personal care products on face and body.
- •On the day of evaluation visit, subject willing not to shower and wash their face and not apply topical hygiene/personal care products on face and body.
- •Subject willing to wear loose fitting soft cotton clothes provided by site.10.Subject willing to have a small 3 mm skin biopsy collected from the back.11.Agreeable to take a COVID-19 RT-PCR test less than 48 hours before evaluation visit.
排除标准
- •If any following non-inclusion criterion applies, the subject must not be included in the study: I.
- •Having a history of skin cancer within the past 5 years.
- •Menopausal female (with absence of menstruations for less than one year) or postmenopausal female (with absence of menstruations for more than one year).
- •Subject with BMI greater than
- •History of allergies, hypersensitivity or any serious reactions to any cosmetic products, and any serious reaction to local anaesthesia, local antibiotic & antiseptic, history of healing defects (hypertrophy, keloid, etc).
- •Subject with any disease state or dermatological disorders affecting the investigational areas (presence ofbums, wounds or irritation, naevi, vitiligo, active/history of psoriasis, moles, active eczema, scars, tattoos, excessive hair etc.) that might impair evaluations or increase the health risk to the subject by participating in the opinion of the Investigator.
- •Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator.
- •Reporting any UV exposure in the past month or planning UV exposure of the face (sunlight or sunbeds) throughout the study.
- •Dermatological or aesthetic procedures on the face and back (deep skin cleansing, dermabrasion, peeling, light-therapy, laser, etc.) within the last 3 months before the screening visit and intending to receive them during the study period.
- •Having used within the 8 past weeks for more than 3 consecutive days any systemic or topical drugs related to antibiotics, anti-inflammatory drug, corticoids, retinoid (topical) or any anti-acne or anti-seborrheic products or having planned to use these treatments during the study.
- •Having used oral lsotretinoin treatment in adolescence or adult age.
- •Having used within the last month before inclusion any depigmenting I whitening or propigmenting (incl.
- •Having used, within the past 6 months, any physical treatment including laser or phototherapy (PUV A, IPL, PDT), Botox or fillers like hyaluronic acid on the investigational sites or having planned to use these treatments during the study.
- •Having used any cosmetic routines such as scrub, deep cleansing of the skin, to the face within past 4 weeks and intended to perfom1 them during the study period.
结局指标
主要结局
To visualize and characterize the presence of skin microbiota as biofilm on healthy and acneic skin
时间窗: baseline visit
using biopsy samples of the back.
时间窗: baseline visit
- To identify acne/phylotype-specific transformations in the immune microenvironments using biopsy
时间窗: baseline visit
samples of the back from healthy and acneic volunteers.
时间窗: baseline visit
- To detect microbial species and phylotypes within the back biopsy from healthy and acneic
时间窗: baseline visit
volunteers.
时间窗: baseline visit
- To isolate and collect the skin microbes for construction of in vitro skin biofilm models.
时间窗: baseline visit
次要结局
- To evaluate other skin clinical parameters: sebum content, skin erythema, itching, dandruff and UV(fluorescence.)
研究者
Dr Annie Jain
CIDP Biotech India Pvt. Ltd.
研究点 (1)
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