CTRI/2020/01/022620已完成不适用
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types
ITC Life Sciences and Technology Centre1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年6月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety assessment of products
研究概览
简要总结
Evaluationof dermatological safety of investigational products by primary irritationpatch test on healthy human volunteers of varied skin types. Test products willbe tested against controls involving 24 subjects. Total study duration is 10days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female subjects in the age group of 18-55 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 willing to give a voluntary written informed consent.
- •6.Subjects having not participated in a similar investigation in the past two weeks.
- •7.Subjects willing to come for regular follow up visits.
- •9.Subjects without any open wounds, cuts, abrasions, irritation symptoms.
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
Safety assessment of products
时间窗: Baseline, 0 hour, 24 hours and 07 Days
次要结局
- Not Applicable(Not Applicable)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Safety assessment of products on skinCTRI/2018/05/013752ITC Life Sciences Technology Centre24
已完成
不适用
Safety assessment of products on skin.CTRI/2018/07/014999ITC Life Sciences Technology Centre24
已完成
不适用
safety of Investigational products by assessing the irritation after patch application onhealthy human volunteers.CTRI/2017/01/007641ITC LIMITED ITC Life Sciences and Technology Centre24
尚未招募
不适用
To study the safety of test product on skin in men and women.CTRI/2025/05/087333Dr. Reddys Laboratories Ltd.26
已完成
不适用
Primary Irritation Patch Test - Normal SkiCTRI/2022/05/042524Curatio Health Care I Private Limited26