Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Subjects with Sensitive 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
- Safety assessment of products
研究概览
简要总结
Cosmetics and Ayurvedic Medicines commonly referred toas personal care products are used by most people on a day to day basis. Theseproducts and materials can be potential sources of cutaneous irritation whichmakes it a necessity to ensure their safety for usage.
Several types of test methods are used widely for theevaluation of safety of cosmetics in human, which include single patch test,in-use test, 7/14/24 days cumulative irritation patch testing (CIPT), humanrepeated insult patch test (HRIPT) for irritation and sensitization potential.
PrimaryIrritation Patch Test (PIPT) is used to determine the potential of the testarticles to cause cutaneous irritation in adult human subjects after single24-hour occluded patch application.
Primary Irritation Patch Test (PIPT) is performed toevaluate the primary skin irritation that can range from none, mild, moderateto severe irritation. This results from reversible inflammatory changes in theskin following 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)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
- •Age: 18-65 years (both inclusive) at the time of consent.
- •Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- •Subject 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 00 prior to patch application.
- •Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumann’s skin type questionnaire.
- •Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
- •Subject is 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.
- •Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- •Subject must be able to understand and provide written informed consent to participate in the study.
排除标准
- •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.
- •Medication which may affect skin response and/or past medical history.
- •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.
- •Subject suffering from any active clinically significant skin diseases which may contraindicate.
- •Participation in any patch test for irritation or sensitization within the last four weeks.
- •Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
- •Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
- •Individual who has a medical condition or is taking or has 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.
- •Participation in other patch study simultaneously.
- •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.
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
- Not Applicable(Not Applicable)