CTRI/2020/03/024322已完成未知
Evaluation of the Cumulative Irritation and Potential for Sensitization of Test Products in Healthy Adult Human Subjects by Repeat Insult Patch Testing
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 240
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 to 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 Subjects who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results
- •5 Subjects in good general health as determined by the Investigator on the basis of medical history
- •6 Subjects willing and able to follow the study directions, to participate in the study returning for all specified visits
- •7 Subjects must be able to understand and provide written informed consent to participate in the study
- •8 Subjects willing to take bath using the same soap or cleansers during the study period.
- •9 Subjects willing to refrain from vigorous physical exercise during the study period.
排除标准
- •1)Subjects 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)Subjects having history of diabetes.
- •4)Subjects 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)Subjects suffering from any active clinically significant skin diseases which may contraindicate.
- •6)Subjects 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)Subjects having history of asthma or COPD (Chronic obstructive pulmonary disease).
- •9)Subjects 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 Investigatorâ??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)Subjects has participation in a clinical drug study or skin irritation/sensitization study during the 30 days preceding the initial patch application in this study.
- •13)Subject reports a history of skin sensitivity to shampoos and detergents or a known hypersensitivity and/or sensitization to medical adhesives.
- •14)Subjects reports use of systemic or topical antihistamines (at any site) or uses of topical drugs at patch site(s) within 72 hours prior to patch application.
- •15)Participation in other patch study simultaneously.
- •16)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 Product application (steroidal nose drops and/or eye drops are permitted).
- •iv.Topical drugs used at application site.
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