EUCTR2006-006443-30-GB进行中（未招募）1 期
A phase IIa open-label study using ICX-RHY to enhance the aesthetic appearance of facial skin imperfections. - The Enhance Trial
Intercytex0 个研究点目标入组 10 人开始时间: 2007年1月7日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Subjects who are healthy and male or female.
- •2.Subjects who are 18 - 55 years of age.
- •3.Subjects with discreet facial skin imperfection(s).
- •4.Subjects with no clinically significant body weight changes in previous 6 months (>5kg weight change).
- •5.Subjects who have voluntarily signed and dated an Informed Consent Form (ICF).
- •6.Subjects, who are, in the opinion of the Investigator, able to understand the study, co-operate with the study procedures and are willing to return to the clinic for all the required follow-up visits.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects with previous use of injectable fillers into the facial skin imperfections.
- •2.Subjects with previous use of cellular therapy (e.g Isolagen).
- •3.Subjects of Afro-Caribbean origin.
- •4.Subjects with a known history of keloids.
- •5.Subjects with a know history of bleeding disorders.
- •6.Subjects with HIV therapy-associated lipodystrophy.
- •7.Subjects with active skin disease (e.g. cysts, infections, rashes, cancer/pre-cancer) in the facial skin imperfections.
- •8.Subjects with active skin infection including acne.
- •9.Subjects with a known allergy to any of the constituents of the product (appendix 3).
- •10.Subjects with known or suspected malignancy.
- •11.Subjects with a life expectancy of <9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc).
- •12.Subjects with an intolerance to additional study-associated drugs/therapies (e.g. isopropyl alcohol, AneStop cream, adrenaline, lignocaine etc).
- •13.Subjects with planned major surgical intervention during the course of the study.
- •14.Subjects taking immunosuppressive therapy including systemic steroids (i.e., oral prednisolone >40mg for more than 1 week, intranasal/inhaled steroids are acceptable) within 90 days of the first treatment or planning immunosuppressive therapy at any time during the study.
- •15.Subjects with known idiopathic or drug-associated coagulopathies.
- •16.Subjects taking medicinal products known to reduce haemostasis (e.g. heparin, coumarins etc) in the 2 weeks prior to commencing treatment or planning to take medicinal products known to reduce haemostasis during the 24 week study period.
- •17.Subjects who have taken any other investigational product within 90 days prior to screening or planned use of any other investigational product during the study period.
- •18.Subjects who are pregnant, planning pregnancy and women of child-bearing potential who are not abstinent or practising an acceptable means of contraception, as determined by the Investigator, for the duration of the treatment phase.
- •19.Subjects with abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range and/or any other abnormal laboratory finding considered clinically significant.
- •20.Subjects with known alcohol or narcotic drug dependence.
研究者
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