CTRI/2022/03/040960已完成未知
Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Subjects with Sensitive Skin.
Honasa Consumer Pvt Ltd0 个研究点目标入组 26 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
- 26
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)Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
- •4)Females of childbearing potential must have a negative urine pregnancy test performed on Day 00 prior to patch application.
- •5)Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannââ?¬•s skin type questionnaire.
- •6)Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
- •7)Subject is in good general health as determined by the Investigator on the basis of medical history.
- •8)Subjects willing to maintain the test patches in designated positions for 24 Hours.
- •9)Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- •10)Subject must be able to understand and provide written informed consent to participate in the study.
- •11)Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.
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 product application (steroidal nose drops and/or eye drops are permitted)
- •iv.Topical drugs used at application site
研究者
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