Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers with sensitive skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 1)Dermatologists Visual Assessment of test site for Irritation.
研究概览
简要总结
The objective of this study is to evaluate the dermatological safety ofthe investigational products on healthy human subjects with sensitive skin andadequate representation of varied skin types (Oily, Dry, Normal andCombination). Thestudy would involve repeated application of the investigational product betweenthe scapula and waist (Para-spinal) region of the subjects across9 days on healthy adult human subject
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
- •1.Healthy male and female subjects in the age group of 18-65 years (both age inclusive).
- •2.Subjects with Fitzpatrick skin type III to V.
- •3.Subjects with good general health as determined by the Investigator on the basis of medical history.
- •4.Subjects who score greater than 30 for section 2 sensitive vs resistant skin in Dr. Baumanns questionnaire.
- •5.Subject who identified to have skin basis Dermatologists assessment of skin with fine texture and closeness of blood vessels to the surface.
- •6.Subjects willing to give a voluntary written informed consent.
- •8.Subjects having not participated in a similar investigation in the past eight weeks.
- •9.Subjects willing to come for regular follow up visits.
- •10.Subjects ready to follow instructions during the study period.
- •11.Subjects without any open wounds, cuts, abrasions, irritation symptoms.
- •Dr. Baumanns questionnaire:- Subjects will need to fill for section 2: sensitive vs resistant skin in the Dr. Baumanns questionnaire and those subjects who score higher than 30 will be classified as having Sensitive skin.
- •Dermats assessment of sensitive skin:- Subjects identified to have fine textured skin and blood vessels close to superficial skin layer will be classified as having Sensitive skin.
排除标准
- •1.Female subject is pregnant, planning for pregnancy, or lactating.
- •2.Subject having skin irritation, pigmentation, pimple, excessive hair, mole, blemishes, marks (e.g. tattoos, scars, sunburn), or any dermatological condition that can interfere with the reading on test sites.
- •3.Medication which may affect skin response and/or past medical history.
- •4.Subject having history of diabetes.
- •5.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.
- •6.Subject suffering from any active clinically significant skin diseases which may contraindicate.
- •8.Participation in any patch test for irritation or sensitization within the last four weeks.
- •9.Subject having history of Bronchial Asthma.
- •10.Subject with Self-reported Immunological disorders such as HIV, AIDS and systemic lupus erythematous.
- •11.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.
- •12.Subject with known allergy or sensitization to medical adhesives, bandages.
- •13.Participation in other patch study simultaneously.
- •14.Use of any: a.Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to enrolment in the current study.
- •b.Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
- •c.Systemic or topical corticosteroids at patch site within four (4) weeks of investigational product application (steroids nose drops and/or eye drops are permitted) d.Topical drugs used at application site.
结局指标
主要结局
1)Dermatologists Visual Assessment of test site for Irritation.
时间窗: 1)Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites. | 2)Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites. | 3)Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites.
2)Subjects’ Self – Assessment of test site for Irritation.
时间窗: 1)Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites. | 2)Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites. | 3)Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites.
3)Instrumental Measurements- measuring erythema using Mexameter and change in skin colour using Chromameter.
时间窗: 1)Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites. | 2)Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites. | 3)Visit 1 to Visit 4 (i.e Day 01 to Day 09), Baseline i.e. before product exposure and 30 minutes post wash of last test sites.
次要结局
- Not Applicable(Not Applicable)