CTRI/2019/07/020072已完成未知
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 Centre0 个研究点目标入组 26 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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.
- •5.Subjects willing to maintain the test patches in designated positions for 24 Hours.
- •6.Subjects having not participated in a similar investigation in the past two weeks.
- •7.Subjects willing to come for regular follow up visits.
- •8.Subjects ready to follow instructions during the study period.
- •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.
- •7.Subject having history of any skin diseases including eczema, atopic dermatitis or active cancer.
- •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 Investigatorâ??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
研究者
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