EUCTR2006-003639-59-GB进行中（未招募）1 期
A phase IIa open-label dose-escalation study using ICX-RHY to enhance the aesthetic appearance of nasolabial folds - RHY IIa
Intercytex0 个研究点目标入组 16 人开始时间: 2006年12月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
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
- 性别
- All
入选标准
- •- Subjects who are healthy and male or female.
- •- Subjects who are =18 - =50 years of age.
- •- Subjects with mild (Grade 3) or moderate (Grade 4) nasolabial folds.
- •- Subjects with symmetrical nasolabial folds.
- •- Subjects with no clinically significant body weight changes in previous 6 months (>5kg weight change).
- •- Subjects who have voluntarily signed and dated an Informed Consent Form (ICF).
- •- 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
- •- Subjects with no (Grade 1), minimal (Grade 2), severe (Grade 5) or very severe (Grade 6) nasolabial folds.
- •- Subjects with previous use of injectable fillers into the nasolabial folds.
- •- Subjects of afro-Caribbean origin.
- •- Subjects with a known history of keloids.
- •- Subjects with a know history of bleeding disorders.
- •- Subjects with HIV therapy-associated lipodystrophy.
- •- Subjects with active skin disease (e.g. cysts, infections, rashes, cancer/pre-cancer) in the nasolabial folds.
- •- Subjects with a known allergy to any of the constituents of the product (appendix 3).
- •- Subjects with known or suspected malignancy.
- •- Subjects with a life expectancy of <9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc).
- •- Subjects with an intolerance to additional study-associated drugs/therapies (e.g. isopropyl alcohol, EMLA cream, adrenaline, lignocaine etc).
- •- Subjects with planned major surgical intervention during the course of the study.
- •- 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.
- •- Subjects with known idiopathic or drug-associated coagulopathies.
- •- Subjects taking medicinal products known to reduce haemostasis (e.g. heparin, coumarins, aspirin etc) in the 2 weeks prior to commencing treatment or planning to take medicinal products known to reduce haemostasis during the 28-day treatment phase.
- •- 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.
- •- 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.
- •- 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.
- •- Subjects with known alcohol or narcotic drug dependence.
研究者
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