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
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
研究概览
简要总结
This is single-centre, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with negative and positive control will be kept in contact with the skin for at least 24 hours (± 2hours).safety will be assessed through the study by monitoring irritation reaction and sufficient number 26 subject will be enrolled to get 24 to complete the study. There are total three visits in this study and one are option(Day01):Screening, Lactic Acid Stinging Test & Modified Dr Baumann’s skin type questionnaire, Enrollment and Patch Application, Visit 02After 24 hours of Application & 30 ± 5 min irritation scoring upon patch removal Visit 03(Day 03): 24 (± 2 hour) irritation scoring (Day 0contacted telephonically on Day 08 for any signs of irritation at patch application site. Follow-up visit for reactions if any to confirm recovery if necessary)Irritation scoring at 168 ± 2 hours post-patch removal(Day 09).
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 equalnumber 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 self-reported negative pregnancy test 5) 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 sunburn), openwounds,cuts,abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that careading.
- •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 anylast 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 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 permitted).
- •Topical drugs used at application site.
- •Subject with Self-reported Immunological disorders such as HIV positive, AIDSand/orsystemic lupus erythematous.
- •Individual who has a medical condition or is taking or has taken a medication which,in theInvestigator’s judgment, makes places the subjectatundue risk.
- •Subject with known allergy or sensitization to medical adhesives, bandages.
- •Participation in other patch study simultaneously.
研究者
Dr Nayan Patel
NovoBliss Research Private Limited