Dermatological Safety Assessment of Test Products Using Primary Irritation Patch Test (PIPT) in Healthy Adult Human Subjects.
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
研究概览
简要总结
This is single-centre, evaluator blinded study in healthy human subjects. single 48-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin for at least 48hours (± 2hours).safety will be assessed through the study by monitoring of adverse event. A sufficient number 26 subject will be enrolled to get 24 to complete the study. There are total four visits in this study. Visit 01 (Day01):Screening, Enrollment and Patch Application, Visit 02 (Day 03): Patch Removal & 30 ± 5 min irritation scoring upon patch removal. Visit 03 (Day 04): 24 (± 2 hour) irritation scoring (Day 04)Visit 05: At 48±2 hours Irritation Scoring
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 VI (Human skin colour determination scale).
- •Females of childbearing potential must have a self-reported negative pregnancy test.
- •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 is willing to refrain from vigorous physical exercise during the study period and follow all the instruction given.
- •For Sensitive Specific Skin Study Only: • Subject scoring greater than 30 for Section 2 – Sensitive v/s Resistant skin in modified Dr Baumann’s skin type questionnaire.
- •• Subject with sensitive skin as confirmed by Lactic Acid Stinging Test.
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).
- •Use of any: i.
- •Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
- •Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
- •Systemic or topical corticosteroids at patch site within four (4) weeks of test product application (steroidal nose drops and/or eye drops are permitted) 10) 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
To evaluate the dermatological safety of the
时间窗: 30+5 minutes of patch removal (Day 03), 24±2 hours of patch removal (Day 04) and 48±2 hours of patch removal (Day 05)
test product by 48 Hours Patch Test Under
时间窗: 30+5 minutes of patch removal (Day 03), 24±2 hours of patch removal (Day 04) and 48±2 hours of patch removal (Day 05)
Complete Occlusion.
时间窗: 30+5 minutes of patch removal (Day 03), 24±2 hours of patch removal (Day 04) and 48±2 hours of patch removal (Day 05)
次要结局
- To evaluate Change in Transepidermal Water Loss (TEWL) by TEWAMeter TM Hex at the application site(at baseline, 30 mins and 24 hours post patch removal)
研究者
Dr Nayan Patel
NovoBliss Research Pvt. Ltd.