CTRI/2022/05/042637已完成未知
Evaluation of dermatological safety of Test Articles by Primary Irritation Patch Test on healthy adult human subjects (Single 24-hour application).
ITC Life Sciences Technology Centre0 个研究点目标入组 25 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 number 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 do 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)Subjects 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.
- •8)Subject must be able to understand and provide written informed consent to participate in the study.
- •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 (within the previous 3 months), 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 having history of diabetes
- •4)Subject have 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.
- •6)Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
- •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/or systemic lupus erythematous.
- •10)Individual who has a medical condition or is taking or has taken a medication which, in the Investigatorââ?¬•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:
- •i.Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
- •ii.Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
- •iii.Systemic or topical corticosteroids at patch site within four (4) weeks of test article application (steroidal nose drops and/or eye drops are permitted)
- •iv.Topical drugs used at application site
研究者
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