NCT03346447已完成不适用
Effect of Baby Wipe Solutions on Fecal Enzyme-induced Irritation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- pH
研究概览
简要总结
This is a single-center, prospective, single-blind pilot study to determine baby wipe formulations on an adult dermatitis model.
详细描述
This is a single-center, prospective, single-blind pilot study to determine baby wipe formulations on an adult dermatitis model.
Biophysical measurements will be taken at each test sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Fluent in English, willing and able to read, understand, and sign the informed consent form (ICF)
- •Ability to complete the course of the study and comply with instructions;
- •Females aged 18 to 40 years, in good general health as deemed by the investigator (no physical required).
- •Caucasian individuals with Fitzpatrick skin type I, II, or III (See Appendix I).
- •Individuals free of any systemic or dermatological disorder including a known history of allergies or other medical conditions which, in the opinion of the investigator, could interfere with the conduct of the study, interpretation of results, or increase the risk of adverse reactions.
- •Anticipated ability to complete the course of the study and to comply with instructions.
- •Females practicing an acceptable method of birth control (abstinence is acceptable). Females of child-bearing potential must have practiced an acceptable method of birth control for the past 3 months and be willing to continue using the same method throughout the duration of the study. Acceptable methods of birth control, include: 1) Systemic birth control (Subjects must have been taking the same type of birth control for at least 3 months prior to entering the study and must not change the type of birth control during the study); 2) Condom with spermicide; 3) IUD; 4) Vasectomized partner; and 5) Abstinence. Females who are post-menopausal (for at least 1 year) or have had a permanent sterilization procedure (i.e. hysterectomy, tubal ligation, bilateral oophorectomy) do not need to have additional birth control methods.
排除标准
- •Individuals with any visible skin disease, skin condition (e.g., back acne) including baseline erythema assessment > 0.5, or tattoos in the test area (mid to upper back).
- •Individuals with abnormal skin pigmentation at the test sites, which might interfere with subsequent evaluations of dermal responsiveness.
- •Individuals with recent prolonged sun or tanning bed exposure in the test area
- •Individuals with excessive dryness or redness at the sites of application.
- •Individuals with a known hypersensitivity to any of the components of the insult, controls, or adhesive tapes.
- •Subjects must not have applied any lotions, creams, powders, or oils to their backs the morning of the study. Additionally, two hours must have passed since bathing or showering.
- •Women who are pregnant or nursing.
- •Individuals who have participated on a study involving the test sites (back) in the previous 30 days.
- •Individuals participating in another clinical study
- •Individuals with open or healing cuts/incisions, abrasions, lesions, pustules, fissures, or broken mucosa/skin in the test area
结局指标
主要结局
pH
时间窗: 1 week
difference in pH between test sites
Erythema
时间窗: 1 week
Time for a test site to reach an erythema score of ≥ 2.
Transepidermal Water Loss (TEWL)
时间窗: 1 week
difference in TEWL between test sites
Chromameter redness
时间窗: 1 week
difference in redness between test sites
次要结局
- Biophysical Measurement changes of skin capacitance(1 week)
- Microbiome profile(1 day)
研究者
研究点 (1)
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