Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Participants with Normal Skin.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Safety assessment of products
研究概览
简要总结
Cosmetics and AyurvedicMedicines commonly referred to as personal care products are used by mostpeople on a day to day basis. These products and materials can be potentialsources of cutaneous irritation which makes it a necessity to ensure theirsafety for usage.
Several types of test methods areused widely for the evaluation of safety of cosmetics in human, which includesingle patch test, in-use test, 7/14/24 Days cumulative irritation patchtesting, human repeated insult patch test (HRIPT) for irritation andsensitization potential.
Primary Irritation Patch Testis performed to evaluate the primary skin irritation that can range from none,mild, moderate to severe irritation. This results from reversible inflammatorychanges in the skin following the application of a test substance depending onthe irritation potential of the product. Based on the severity of irritationcaused due to the interaction of ingredients or composition of the testsubstance with the skin can cause perceivable sensations or symptoms. On thebasis of this, the possible hazards likely to arise from exposure of the skinto the test substance can be assessed. To know the safety or possible irritantpotential of these products, it should be tested in small group of humansbefore release of the product in market. This allows to measure and evaluatethe probable inflammatory response to an irritant which occurs only at the siteof exposure. The response tends to be universal (produces a reaction in mostindividuals) and depends on the strength and duration of exposure.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and non-pregnant/non-lactating females (preferably equal numbers of males and females) between age group of 18 to 65 years (both inclusive) at the time of consent.
- •Participants 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.
- •Participants who do not have any previous history of adverse skin conditions and are not under any medication are likely to interfere with the results.
- •Participants willing to maintain the test patches in designated positions for 24 Hours and refrain from vigorous physical exercise during the study period.
- •Participants willing and able to follow the study directions to participate in the study, return for all specified visits.
- •Participants must be able to understand and provide written informed consent to participate in the study.
排除标准
- •Participants 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.
- •Participant 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.
- •Participant suffering from any active clinically significant skin diseases which may affect the study results.
- •Participant having history of any skin diseases including eczema, atopic dermatitis.
- •Participation in any patch test for irritation or sensitization within the last four weeks.
- •Participants taking part in another study liable to interfere with the results of this study.
- •Participants with self-reported Immunological disorders such as HIV positive, AIDS and systemic lupus erythematous.
- •Participants with a medical condition or are taking or have taken a medication which, in the Investigator’s judgment, makes the Participant ineligible or places the Participant at undue risk.
- •Participant with known allergy or sensitization to medical adhesives, bandages.
- •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 (steroids nose drops and/or eye drops are permitted).
- •iv.Topical drugs used at application site.
结局指标
主要结局
Safety assessment of products
时间窗: 30 minutes of patch removal (Day 02), 24 hours (Day 03) and 168 hours (Day 09)
次要结局
未报告次要终点