NCT05094700已完成不适用
A Single Center, Monadic, Open Label, Four-Week Clinical Trial to Evaluate the Tolerance and of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Patients
Johnson & Johnson Consumer Inc. (J&JCI)2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2021年10月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Mildness of the Facial Cleanser in Participants with Sensitive Skin Based on Investigator and Participant Assessments
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and tolerance of a gentle facial cleanser in participants with sensitive skin (eczema/atopic dermatitis, rosacea, acne, cosmetic intolerance syndrome).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18-70 years of age. Participants who are over 65 years of age must be Coronavirus Disease 2019 (COVID-19) vaccinated. The site will review state issued vaccination cards as proof of vaccination
- •Fitzpatrick Skin Type I-VI, across a range of races and ethnicities with at least 2 participants per each Fitzpatrick skin type
- •Participants who possess mild to moderate eczema/atopic dermatitis, mild to moderate rosacea, mild to moderate acne, or mild to moderate cosmetic intolerance syndrome
- •Participants willing to continue normal course of treatment (within the past 30 days) for their skin disease/condition with no changes during the study
- •Participants must provide written informed consent including consent for photograph release including Health Insurance Portability and Accountability Act (HIPAA) disclosure
- •Able to read, write, speak, and understand English
- •Generally in good health based on medical history reported by the participant
- •Intends to complete the study and is willing and able to follow all study instructions
排除标准
- •Has very sensitive skin and/or has known allergies or adverse reactions to common topical skincare products or to ingredients in the investigational product (IP) or have demonstrated a previous hypersensitivity reaction to any of the ingredients in the IP
- •Participants who are pregnant, breast feeding, or planning to become pregnant
- •Participants with clinically significant unstable medical disorders
- •Participants who are unwilling or unable to comply with the requirements of the protocol
- •Participants who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study
- •Participants with any planned surgeries and/or invasive medical procedures during the course of the study
- •Participants who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study
- •Presents with a skin or condition that, in the principal investigator (PI) or designee's opinion, may confound the study results or otherwise be inappropriate for study participation (example, pre-existing or dormant facial dermatologic conditions specifically severe acne or acne conglobata, psoriasis, rosacea, rashes, eczema, atopic dermatitis, skin cancer, many and/or severe excoriations, observable suntan, scars, nevi, tattoo, excessive hair, Et cetera [etc])
- •Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
- •Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including: a) Immunosuppressive or steroidal drugs within 2 months before Visit 1; b) Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; c) Antihistamines within 2 weeks before Visit 1
- •Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
- •Is simultaneously participating in any other product-use study or has participated in another clinical study on the face in the past 4 weeks
- •Participants currently receiving any anticancer, immunosuppressive treatments/medications (example, azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.), or radiation as determined by study documentation
- •Participants with a history of immunosuppression/immune deficiency disorders (including [human immunodeficiency virus {HIV} infection or acquired immunodeficiency syndrome {AIDS})
- •Is participating or receiving any professional or aesthetic facial spa procedures during the study
- •Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor
- •Has a history of a confirmed COVID-19 infection within 30 days prior to Visit 1
- •Has had contact with a COVID-19-infected person within 14 days prior to Visit 1
- •Individual or a member of the individual's household has traveled internationally within 14 days prior to Visit 1
- •Has experienced any of the following self-reported symptoms of COVID-19 within 2 weeks prior to Visit 1: a) Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomachaches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, fever, or chest pain/tightness; b) Temperature greater than or equal to (>=) 37.5 degree Celsius (°C) / 99.5 degree Fahrenheit (°F), measured; c) Use of fever reducers within 2 days prior to each on-site visit
结局指标
主要结局
Mildness of the Facial Cleanser in Participants with Sensitive Skin Based on Investigator and Participant Assessments
时间窗: Baseline to Week 4
Mildness of the facial cleanser in participants with sensitive skin (eczema/atopic dermatitis, rosacea, acne, cosmetic intolerance syndrome) based on investigator and participant assessments will be reported. It will be evaluated on a scale of 0 to 4 with 0=none, 1=almost clear, 2=mild, 3=moderate, 4=severe.
次要结局
- Investigator Assessment for Tolerability(Baseline, Week 2 and Week 4)
- Investigator Assessment for Efficacy(Baseline, Week 2 and Week 4)
- Participant Assessment for Tolerability(Baseline, Week 2 and Week 4)
- Participant Assessment for Efficacy(Baseline, Week 2 and Week 4)
- Photographic Imaging (Right, Left and Frontal Face with Standard Lighting 1 and Cross Polarized Light)(Baseline, Week 2 and Week 4)
- Non-invasive Assessment: Transepidermal Water Loss (TEWL)(Baseline, Week 2 and Week 4)
- Non-invasive Assessment: Skin pH(Baseline, Week 2 and Week 4)
- Non-invasive Assessment: Skin Hydration Measured by Corneometer(Baseline, Week 2 and Week 4)
- Non-invasive Assessment: Biomarker Tapes(Baseline, Week 2 and Week 4)
- Non-invasive Assessment: Facial Swabbing(Baseline, Week 2 and Week 4)
研究者
研究点 (2)
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