CTRI/2019/10/021522已完成不适用
Evaluation of Dermatological Safety of Test Articles by Primary Irritation Patch Test on Healthy Adult Human Subjects (Single 24-hour Application).
DMB Healthcare1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年10月15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
- 26
- 试验地点
- 1
- 主要终点
- Safety assessment of products
研究概览
简要总结
Evaluationof dermatological safety of investigational products by primary irritationpatch test on healthy human volunteers of varied skin types. Test products willbe tested against controls involving 24 subjects. Total study duration is 09days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age: 18-65 years (both inclusive) at the time of consent.
- •2.Sex: Males and non-pregnant/non-lactating females (preferably equal numbers of males and females).
- •3.Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
- •4.Subject who does not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
- •5.Subject is in good general health as determined by the Investigator on the basis of medical history.
- •6.Subject willing to maintain the test patches in designated positions for 24 Hours.
- •7.Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- •9.Subject is willing to refrain from vigorous physical exercise during the study period.
排除标准
- •1.Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos, scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
- •2.Medication which may affect skin response and/or past medical history.
- •3.Subject with history of diabetes.
- •4.Subject with history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
- •5.Subject suffering from any active clinically significant skin diseases which may contraindicate.
- •7.Participation in any patch test for irritation or sensitization within the last four weeks.
- •8.Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
- •9.Subject with self-reported Immunological disorders such as HIV positive, AIDS and systemic lupus erythematous.
- •10.Individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
- •11.Subject with known allergy or sensitization to medical adhesives, bandages.
- •12.Participation in other patch study simultaneously.
- •13.Use of any: a.Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to enrolment in the current study.
- •b.Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
- •c.Systemic or topical corticosteroids at patch site within four (4) weeks of investigational product application (steroids nose drops and/or eye drops are permitted) d.Topical drugs used at application site.
结局指标
主要结局
Safety assessment of products
时间窗: Baseline, 0 hour, 24 hours and 168 hours
次要结局
- Not Applicable(Not Applicable)
研究者
研究点 (1)
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