Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under CompleteOcclusion | Semi Occlusion |Open Patch on Adult Healthy Human Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To evaluate the dermatological safety of the test
研究概览
简要总结
This is single-center, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin if subject under icclllusion | semi occlusion | open patch for at least 24 hours (± 2 hours). safety will be assed through the study by monitoring of adverse event.
A sufficient number 26 subject will be enrolled to get 24 completed the study.
There are total three visits in this study and are optional visit
Pre-screening visit : Lactic Acid Stinging test& Modified Dr baumenn’s skin type questionnaire.
Visit 01: Screening, Enrollment, and Patch Application (Day 01).
Visit 02: Patch Removal After 24 hours of Application & 30 ± 5 min irritation scoring upon patch removal.
Visit 03: 24 (± 2 hour) irritation scoring (Day 03) visit 04: subject will be contacted telephonically on Day 08 for any signs of irritation at patch application site.
Follow-up visit for reactions if any to confirm recovery (optional deemed 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
- 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
- •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.
- •The subject is in good general health as determined by the Investigator on the basis of medical history.
- •Subjects are 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 instructions 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.
- •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)
- •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 test
时间窗: 30 mins, 24 Hour & 168 hour (if needed).
products by 24 Hours Patch Test Under
时间窗: 30 mins, 24 Hour & 168 hour (if needed).
Complete Occlusion on healthy adult human
时间窗: 30 mins, 24 Hour & 168 hour (if needed).
subjects & adequate representation of varied
时间窗: 30 mins, 24 Hour & 168 hour (if needed).
skin types (Oily, Dry, Normal & Combination).
时间窗: 30 mins, 24 Hour & 168 hour (if needed).
次要结局
- Safety of the skin(At 30 mins & 24 hours post patch removal.)