EUCTR2006-005396-17-IT进行中（未招募）不适用
A prospective, randomized, double-blind, international multicenter trial to investigate the efficacy and safety of NT 201 in comparison to placebo and to compare two different application schemes of NT 201 in the treatment of lateral periorbital wrinkles - NT crow's feet
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
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
- •1.Moderate (severity score of 2) to severe (severity score of 3)symmetrical lateral periorbital wrinkles assessed by the investigator according to RNKLS
- •2. Symmetrical lateral periorbital wrinkles on both sides of the face
- •at rest and at maximum smile
- •3. Man or woman between 18 and 60 years of age (inclusively)
- •4. Stable medical condition
- •5. Sum score of the evaluated questionnaire on quality of life, skin
- •and cosmetics [FLQA-c] must be below the predefined cut-off
- •value of 0 2
- •6. Willingness of the subject to participate as documented by written
- •informed consent
- •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.Significant facial asymmetry3
- •2. Previous facial surgery, e.g. face-lifting
- •3. Wrinkles not caused by muscular contractions
- •4.Previous treatment with Botulinum toxin of any serotype within
- •the last 6 months
- •5. Previous treatment with bio-degradable fillers in the periorbital
- •area within the last 12 months
- •6. Any previous insertion of permanent material in the periorbital
- •area (regardless of the time between previous treatment and this
- •7.Any facial cosmetic procedure (e.g., dermal filling, chemical
- •peeling, photo rejuvenation) in the periorbital area within the last
- •8. Planned concomitant treatment with Botulinum toxin of any
- •serotype in any body region during the study period
- •9. Any other planned facial aesthetic procedure during the study period
- •10. Inability to substantially reduce lateral periorbital wrinkles by
- •physically spreading them apart
- •11. Any infection in the area of the injection sites
- •12. Any previous surgery or scars in the periorbital area
- •13. Any medical condition that may put the subject at increased risk by exposure to NT 201 or one of the ingredients of the formulation
- •14. Bleeding disorders
- •15. Regular intake of drugs with anticoagulative effect (e.g.,
- •warferin, heparin, cumarines, clopidogrel) within the last 10 days
- •16. Regular intake of vitamin E or calcium channel blockers within the last 10 days
- •17. Concurrent use of aminoglycoside antibiotics or other agents that
- •might interfere with neuromuscular function or that might interfere with the action of Botulinum toxin A
- •18. Diagnosis of Lambert Eaton syndrome/myasthenia gravis, amyotrophic lateral sclerosis or any other significant neuromuscular disease that might interfere with this study
- •19. Facial or skin conditions that in the opinion of the investigator could affect safety and/or efficacy results (e.g., acne, scars, psoriasis, allergic dermatitis, photodamage)
- •20. History of facial nerve palsy, ptosis, weakness of periorbital muscles etc.
- •21. Laxity of the lower lid
- •22. If in the opinion of the investigator the subject has unrealistic
- •expectations
- •23. Pregnant woman, verified by a positive pregnancy test
- •24. Nursing woman or woman of childbearing potential without
- •reliable means of contraception (reliable contraception defined as
- •hormonal contraception or intrauterine contraceptive device or combination of two barrier methods [e.g. condom or diaphragm plus spermicidal cream]) or woman planning pregnancy during the course of the trial
- •25. If in the opinion of the investigator the subject is unlikely to
- •complete all study visits.
- •26. Participation in a clinical study within 30 days prior to the screening visit
- •27. Previous randomization in this clinical study
- •28. Other contraindications which in the investigator?s opinion
- •preclude participation in the study
- •29. Evidence of recent alcohol or drug abuse
- •30. Employees or direct relatives of an employee of the CRO, the
- •Study Center or Merz Pharmaceuticals
研究者
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