A prospective, open-label, international, multicenter trial to investigate the efficacy and safety of NT 201, free of complexing proteins, in the treatment of glabellar frown lines - NT-SPUTNIK
- Conditions
- Treatment of glabellar frown linesMedDRA version: 10.1Level: LLTClassification code 10052609Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2008-000549-73-DE
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 101
1. Moderate to severe glabellar frown lines at maximum frown as assessed by the investigator according to FWS
2. Age: between 18 and 65 years (inclusively)
3. Stable medical condition (assessed at Visit 2 and defined in the protocol)
4. Willing and able to complete the entire course of the trial and to comply with trial instructions
5. 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
1. Previous treatment with Botulinum toxin of any serotype in the upper third part of the face within the last 6 months
2. Previous treatment with biodegradable fillers in the glabellar area within the last 12 months
3. Previous insertion of permanent material in the glabellar area, including fat graft (regardless of the time between previous treatment and this study)
4. Previous treatment with any facial cosmetic procedure (e.g. chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months
5. Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area
6. Any other planned cosmetic procedure in the upper third part of the face during the trial period
7. Inability to substantially lessen glabellar frown lines even by physically spreading them apart
8. Marked facial asymmetry or ptosis of eyelid and/or eyebrow
9. History of facial nerve palsy
10. Any infection in the area of the injection sites
11.Any medical condition that may put the subject at increased risk with exposure to NT 201, including diagnosed myasthenia gravis, Lambert-Eaton Syndrome, amyotrophic lateral sclerosis or any other disorder that might interfere with neuromuscular function
12. Bleeding disorders or intake of drugs in doses that will lead to an anticoagulative effect (e.g. heparin, cumarines, clopidogrel, non-steroidal anti-inflammatory drugs, acetylsalicylic acid) 10 days before injection
13. Intake of any of the forbidden concomitant medication, e. g. aminoglycoside antibiotics, or other agents that might interfere with neuromuscular function (e.g. D-penicillinamine, curarine-type muscle relaxants, succinylcholine) or might interfere with the action of Botulinum toxin (e.g. chloroquine)
14. Known allergy or sensitivity to the trial medication or its components
15. Pregnancy , nursing, or planning of pregnancy during the trial period, or no usage of appropriate methods of contraception (such as implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomised partner) by females of childbearing potential
16. Evidence of recent alcohol or drug abuse
17. Psychiatric problems that, in the investigator’s opinion, are severe enough to interfere with trial results
18. Participation in another clinical trial within 30 days prior to screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method