Evaluation of the cumulative irritation and potential for sensitization of test products in healthy adult human subjects by repeat insult patch testing.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- To evaluate the test product(s) for the induction of cumulative irritation and contact sensitization by repetitive applications to the skin of human volunteers and to report any irritation observed with the test products
研究概览
简要总结
This is single-center, evaluator-blinded, skin irritation and sensitization study in healthy adult human subjects using repeat insult patch testing. Study can be conducted in multiple groups.
Duration will be approximately 6 weeks which includes an Induction phase (19 days) and Challenge phase (6 days)
Visit 01 : Screening
Visit 02 (Day 01): Induction Phase, Patch application
Visit 03, 05, 07, 09, 11, 13, 15, 17, 19 (Day 02, 04, 06, 08, 10, 12, 14, 16, 18 respectively): Patch removal
Visit 04, 06, 08, 10, 12, 14, 16, 18, and 20 (Day 03, 05, 07, 09, 11, 13, 15, 17, and 19): Irritation scoring and patch application. On day 19 only irritation scoring will be performed.
Rest Phase: Day 20 to Day 35
Visit 21 (Day 36): Challenge Patch Application
Visit 22 (Day 37): Challenge patch removal
Visit 23 (Day 38): Irritation scoring (24 ± 2hrs)
Visit 24 (Day 39): Irritation scoring (48 ± 2hrs)
Visit 25 (Day 40): Irritation scoring (72± 2hrs)
Visit 26 (Day 42): Irritation Scoring ((120± 2hr, optional visit for subjects safety)
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 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 numbers of males and females).
- •Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
- •Subjects who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
- •Subjects in good general health as determined by the Investigator on the basis of medical history.
- •Subjects willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- •Subjects must be able to understand and provide written informed consent to participate in the study.
- •Subjects willing to take bath using the same soap/cleansers during the study period.
- •Subjects willing to refrain from vigorous physical exercise during the study period.
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.
- •Subjects having history of asthma or COPD (Chronic obstructive pulmonary disease).
- •Subjects 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.
- •Subjects has participation in a clinical drug study or skin irritation/sensitization study during the 30 days preceding the initial patch application in this study.
- •Subject reports a history of skin sensitivity to shampoos and detergents or a known hypersensitivity and/or sensitization to medical adhesives.
- •Subjects reports use of systemic or topical antihistamines (at any site) or uses of topical drugs at patch site(s) within 72 hours prior to patch application.
- •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.
- •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).
- •Topical drugs used at application site.
结局指标
主要结局
To evaluate the test product(s) for the induction of cumulative irritation and contact sensitization by repetitive applications to the skin of human volunteers and to report any irritation observed with the test products
时间窗: After usage of the test product from Day 02 to Day 42 by the dermatologist (As per protocol)
induction phase:
时间窗: After usage of the test product from Day 02 to Day 42 by the dermatologist (As per protocol)
1)To confirm that the test products are irritating or not when applied over a continuous 21-day period.
时间窗: After usage of the test product from Day 02 to Day 42 by the dermatologist (As per protocol)
2) To evaluate the safety of test products
时间窗: After usage of the test product from Day 02 to Day 42 by the dermatologist (As per protocol)
Challenge phase
时间窗: After usage of the test product from Day 02 to Day 42 by the dermatologist (As per protocol)
1)To evaluate the incidence of potential sensitization reactions observed for the test products.
时间窗: After usage of the test product from Day 02 to Day 42 by the dermatologist (As per protocol)
Rechallenge phase
时间窗: After usage of the test product from Day 02 to Day 42 by the dermatologist (As per protocol)
1) To evaluate the potential sensitization reaction of the test product if observed in challenge phase.
时间窗: After usage of the test product from Day 02 to Day 42 by the dermatologist (As per protocol)
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited