CTRI/2024/02/062767招募中Unknown
A Mono-center, matched-Control Study to Investigate the Skin Biofilm Profile on Asian Acne Volunteers Compared to Healthy Volunteers. - NI
SCELSE0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
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. b. 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. Nursing, pregnant, or is planning to be pregnant according to subject self-report during the
- •2. Having a history of skin cancer within the past 5 years.
- •3. Menopausal female (with absence of menstruations for less than one year) or post menopausal female (with absence of menstruations for more than one year).
- •4. Subject with BMI greater than 30.
- •5. 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).
- •6. 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.
- •7. Any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator.
- •8. Reporting any UV exposure in the past month or planning UV exposure of the face
- •(sunlight or sunbeds) throughout the study.
- •9. 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.
- •I 0. 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
- •I I. Having used oral lsotretinoin treatment in adolescence or adult age.
- •I 2. Having used within the last month before inclusion any depigmenting I whitening or pro pigmenting (incl. self-tanning) topical treatments or having planned to use these treatments
- •during the study on the face.
- •I 3. 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.
- •I 4. 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.
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