Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test Under Complete Occlusion or Semi Occlusion or Open Patch on Adult Healthy Human Subjects
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 主要终点
- Change from Irritation Potential of the test product from Baseline to Post application
研究概览
简要总结
This is a single-center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion for at least 24 hours (+ 2 hours). The study can be conducted in a single group. Safety will be assessed throughout the study by monitoring adverse events.
The subject's back between the scapula and waist will be utilized as application sites. Application sites will be evaluated for scoring the reaction, namely, erythema, dryness, and wrinkles on a 0-4 point scale separately for each parameter and edema on another 0-4 points scale as per the Draize Scale after 30+5 minutes of patch removal, 24±2 hours and 168±2 hours after patch removal.
详细描述
The objective of this study is to evaluate the dermatological safety of the test products by 24 Hours patch test under complete occlusion on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal, and Combination).
This is a single-center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion for at least 24 hours (+ 2 hours). The study can be conducted in a single group. Safety will be assessed throughout the study by monitoring adverse events. The subject's back i.e. between the scapula and waist will be utilized as application sites.
26 subjects with varied skin types (Oily, Dry, Normal, and Combination, preferably equal ratio) will be enrolled in the study to get 24 completed subjects at the end of study.
The expected total study duration will be approximately 9 days from patch application day.
The duration of this study will be 9 days from enrollment day. There are total of 3 visits in this study and one optional visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Evaluator Blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 01 prior to patch application.
- •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 is 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.
- •Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.
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
- •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.
- •Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
- •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).
- •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)
- •Topical drugs used at application site.
- •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.
结局指标
主要结局
Change from Irritation Potential of the test product from Baseline to Post application
时间窗: Irritation Scoring at 30 minutes, and 24 hours, 168 hours post patch removal.
To evaluate the dermatological irritation potential of the test products by applying Patch Test Under Complete Occlusion for continuous 24 Hours exposure on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal and Combination)
次要结局
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(At 30 minutes (on Day2) and 24 hours (on Day 3) post patch removal and up to 9 days from the Day 1.)
研究者
Dr Nayan Patel
Principal Investigator
NovoBliss Research Pvt Ltd