CTRI/2025/04/085059已完成不适用
Evaluation of dermatological safety of test products by Primary Irritation Patch Test on healthy subjects with normal skin. (Single 24-hour Application).
ITC Life Sciences & Technology Centre1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年9月5日
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
Single application, semi occlusive and closed occlusive patch study.
Duration of study: 9 Days as per BIS Standard
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Indian males and non-pregnant/non-lactating females (preferably equal numbers of males and females) between age group of 19 to 65 years (both inclusive) at the time of consent.
- •Subjects with normal Fitzpatrick skin type III to V.
- •(Human skin colour determination scale).
- •Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
- •Subjects who do not have any previous history of adverse skin conditions and are not under any medication are likely to interfere with the results.
- •Subjects are in good general health as determined by the Investigator on the basis of medical history.
- •Subjects willing to maintain the test patches in designated positions for 24 Hours and refrain from vigorous physical exercise during the study period.
- •Subjects willing and able to follow the study directions to participate in the study, return for all specified visits.
- •Subjects must be able to understand and provide written informed consent to participate in the study.
- •Subjects having valid proof of identity and age.
排除标准
- •Subjects having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g., tattoos, scars, and 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.
- •Subject with history of asthma or COPD (Chronic obstructive pulmonary disease), diabetes and mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
- •Subject suffering from any active clinically significant skin diseases which may affect the study results.
- •Subject having history of any skin diseases including eczema, atopic dermatitis.
- •Participation in any patch test for irritation or sensitization within the last four weeks.
- •Subjects taking part in another study liable to interfere with the results of this study.
- •Subjects with self-reported Immunological disorders such as HIV positive, AIDS and systemic lupus erythematous.
- •Subjects with a medical condition or are taking or have taken a medication which, in the Investigator’s judgment, makes the Subject ineligible or places the Subject at undue risk.
- •Subject with known allergy or sensitization to medical adhesives, bandages.
- •Use of any: a.Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
- •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 test 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: 24hrs post patch removal (Day 03)
次要结局
- Safety Assessment of Products(30 mins post patch removal (Day 03))
研究者
研究点 (1)
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