Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Subjects with Normal Skin.
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
- To evaluate the dermatological safety of the test products by 24 Hours Patch Test Under Complete Occlusion on healthy human participants with normal skin.
研究概览
简要总结
Cosmetics products commonly referred to as personal care products areused by most people on a day-to-day basis. These products and materials can bepotential sources of cutaneous irritation which makes it a necessity to ensuretheir safety for usage.
Several types of test methods are used widely for the evaluation ofsafety of cosmetics in human, which include single patch test, in-use test,7/14/24 days cumulative irritation patch testing (CIPT), human repeated insultpatch test (HRIPT) for irritation and sensitization potential.
Primary Irritation Patch Test (PIPT) is performed to evaluate theprimary skin irritation that can range from none, mild, moderate to severeirritation. This results from reversible inflammatory changes in the skinfollowing the application of a test substance depending on the irritationpotential of the product. Based on the severity of irritation caused due to theinteraction of ingredients or composition of the test substance with the skincan cause perceivable sensations or symptoms. On the basis of this, thepossible hazards likely to arise from exposure of the skin to the testsubstance can be assessed. To know the safety or possible irritant potential ofthese products, it should be tested in small group of humans before release ofthe product in market. This allows to measure and evaluate the probableinflammatory response to an irritant which occurs only at the site of exposure.The response tends to be universal (produces a reaction in most individuals) anddepends 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 are in good general health as determined by the Investigator on the basis of medical history.
- •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.
- •Participants having valid proof of identity and age.
排除标准
- •Participants having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (example tattoos, scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) that is 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 six 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 Investigators 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: a.Prescribed or over-the-counter (OTC) anti-inflammatory drug within five days prior to application.
- •b.Antihistamine medication or immunosuppressive drugs within seven days prior to first patch application.
结局指标
主要结局
To evaluate the dermatological safety of the test products by 24 Hours Patch Test Under Complete Occlusion on healthy human participants with normal skin.
时间窗: 30 minutes of patch removal (Day 02), 24 hours (Day 03) and 168 hours (Day 09)
次要结局
- Not Applicable(Not Applicable)