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
- 尚未招募
- 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
Cosmeticsproducts commonly referred to as personal care products are used by most peopleon a day to day basis. These products and materials can be potential sources ofcutaneous irritation which makes it a necessity to ensure their safety forusage.
Severaltypes of test methods are used widely for the evaluation of safety of cosmeticsin human, which include single patch test, in-use test, 7/14/24 Days cumulativeirritation patch testing, human repeated insult patch test (HRIPT) forirritation and sensitization potential.
PrimaryIrritation Patch Test is performed to evaluate the primary skin irritation thatcan range from none, mild, moderate to severe irritation. This results fromreversible inflammatory changes in the skin following the application of a testsubstance depending on the irritation potential of the product. Based on theseverity of irritation caused due to the interaction of ingredients orcomposition of the test substance with the skin can cause perceivablesensations or symptoms. On the basis of this, the possible hazards likely toarise from exposure of the skin to the test substance can be assessed. To knowthe safety or possible irritant potential of these products, it should betested in small group of humans before release of the product in market. Thisallows to measure and evaluate the probable inflammatory response to anirritant which occurs only at the site of exposure. The response tends to beuniversal (produces a reaction in most individuals) and depends on the strengthand 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.
- •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 scoring greater than 30 for Section 2- Sensitive versus Resistant skin in modified Dr. Baumann’s skin type questionnaire.
- •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.
- •Participation in other patch study simultaneously.
- •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: I.Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to 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