EUCTR2019-001151-40-DE进行中（未招募）1 期
Phase II pilot study: To determine an effective and tolerable dose of Hylase® Dessau (bovine hyaluronidase) in the treatment of hyaluronic acid filler overshoots by injection into defined areas of hyaluronic acid oversprayed areas of healthy volunteers
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 57
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
- •Female and male subjects aged = 18 years and =65 years
- •Written consent of study participants and ability to understand and follow the study and instructions
- •Healthy subjects in good physical condition
- •Heart rate >50 bis <90 beats/Minute and blood pressure of systolic >90 to <140 and diastolic >50 to <90 mmHg
- •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 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •1. Known hypersensitivity to hyaluronidase, bovine proteins and / or gelatin
- •2. Pregnancy or breastfeeding throughout the study period
- •3. Women of childbearing potential who do not use contraceptive methods with a Pearl Index = 1, eg. Eg pill, implant, depot injection, sterilization (exception: menopause since =1 year)
- •4. Subjects with congenital heart disease, venous congestion or shock symptoms
- •5. Subjects with infections or infected treatment area
- •6. Known insect poison allergy
- •7. Subjects with infections, wounds and skin diseases and / or caused by stitches or bites swelling in the treatment area
- •8. Existing alcohol and / or drug addiction
- •9. Subjects simultaneously taking medicines containing antihistamines, heparin, morphine, chondroitin sulfate B, cholic acid, dicumarol, vitamin C, flavonoids, sulphonate detergents, salicylic acid derivatives and heavy metal ions (Fe, Mn, Cu, Zn, Hg), salicylic acid derivatives, histamine, calcium or phosphates. These substances can inhibit or enhance the action of the hylase.
- •10. Subjects with Cancer and Autoimmune Diseases (e.g., psoriasis)
- •11. Subjects with known immune deficiency
- •12. Tendency to keloid formation and / or hypertrophic scarring
- •13. Participation in another study within the last 30 days
- •14. Subjects who are unwilling or unable to follow the requirements of the protocol
- •15. Employees / Relatives of the Sponsor or Employees / Relatives of the Head of the Clinical Trial (LKP)
研究者
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