CTRI/2021/07/034825已完成未知
Evaluation of dermatological safety of Three investigational products by a 24-hour patch test to assess the irritation potential on healthy volunteers
Mr Amol Khedkar0 个研究点目标入组 0 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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Healthy male and female volunteers aged 18 to 65 with no active dermatological conditions
- •2.Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination
- •3.Subjects who have intact skin on the proposed application site; dorsum (scapular region)
- •4.Fitzpatrick photo type I to IV skin type
- •5.Willingness to participate as evidenced by voluntary written informed consent
排除标准
- •1.Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- •2.Women who are breast-feeding
- •3.Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
- •4.Presence of open sores, pimples, or cysts at the application site.
- •5.Active dermatosis (local or disseminated) that might interfere with the results of the study.
- •6.Considered immune compromised.
- •7.History of diseases aggravated or triggered by ultraviolet radiation.
- •8.Participants with dermatographism.
- •9.Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.
- •10.Use of the following topical or systemic medications: immunosuppressants, antihistamines, nonhormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit.
- •11.Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit
- •12.Intention of being vaccinated during the study period or vaccination within 3 weeks of the screening visit.
- •13.Currently receiving allergy injections, or due to receive an injection within 7 days prior to Visit1, or expects to begin injections during study participation
- •14.Previous history of atop, allergic reactions, irritation or intense discomfort feelings to topical use products, cosmetics, or medication
- •15.Known or suspected intolerance or hypersensitivity to any of the study
- •materials (or closely related compounds) or any of their stated ingredient including any component of the patches
- •16.History of sensitization in a previous patch study
- •17.Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30days of the screening visit
- •18.Recent history (within the last years) of alcohol or other substance abuse
研究者
相似试验
尚未招募
不适用
To Assess the dermatological safety of 3 investigational products, by a 24-hour patch test on healthy volunteersCTRI/2021/07/035026Skinovate Laser Cosmetic Surgery Centre
已完成
不适用
To test the safety of 3 test products for skin irritatioCTRI/2020/08/027431Sun Pharmaceutical Industries Ltd56
已完成
不适用
To test the safety of 3 test products for skin irritatioCTRI/2021/03/032023Sun Pharmaceutical Industries Ltd56
已完成
不适用
To evaluate safety of 3c test products for skin irritation.CTRI/2021/08/035395Sun Pharmaceutical Industries Ltd53
已完成
不适用
Dermatological Safety Study on skin of Healthy Human SubjectsCTRI/2021/03/032229Vasu Research Centre A division of Vasu Healthcare Pvt Ltd24