A prospective, randomized, double-blind, placebo-controlled, multicenter trial with an open-label extension period to investigate the efficacy and safety of NT 201, free of complexing proteins, in the treatment of glabellar frown lines
- Conditions
- Treatment of glabellar frown linesMedDRA version: 8.1Level: LLTClassification code 10052609Term: Glabellar frown lines
- Registration Number
- EUCTR2005-004416-78-DE
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 255
·Moderate to severe glabellar frown lines at maximum frown as assessed by the investigator according to FWS
·Stable medical condition
·18 years of age or older
·Sum score below cut-off in evaluation based on FLQA-k questionnaire
·Willing and able to complete the entire course of the trial and to comply with trial instructions
·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) yes
F.1.3.1 Number of subjects for this age range
·Previous treatment with Botulinum toxin of any serotype or with biodegradable fillers in the glabellar area within the last 12 months
·Any previous insertion of permanent material in the glabellar area (regardless of the time between previous treatment and this study)
·Previous treatment with any facial cosmetic procedure (e.g. dermal filling, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months
·Planned treatment with Botulinum toxin of any serotype in any body region during the study period
·Any other planned facial cosmetic procedure during the trial period
·Inability to substantially lessen glabellar frown lines even by physically spreading them apart
·Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilli muscles or a combination of these, or scars in the glabellar area
·Marked facial asymmetry or ptosis of eyelid and/or eyebrow
·Any infection in the area of the injection sites
·Any medical condition that may put the patient 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
·History of facial nerve palsy
·Bleeding disorders or regular intake of drugs with anticoagulative effect within the last 10 days before Screening (e.g. heparin, cumarines, clopidogrel, non-steroidal anti-inflammatory drugs, acetylsalicylic acid in doses higher than 100 mg)
·Concurrent use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function (e.g. D-penicillinamine, curarine-type muscle relaxants, succinylcholine) or that might interfere with the action of Botulinum toxin (e.g. chloroquine)
·Evidence of recent alcohol or drug abuse
·Psychiatric problems that, in the investigator’s opinion, are severe enough to interfere with trial results
·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
·Known allergy or sensitivity to the trial medication or its components
·Participation in another clinical trial within 30 days prior to Screening
·Any condition or situation that in the investigator’s opinion may put the patient at significant risk, may confound the trial results, or may interfere significantly with the patient’s participation in the trial
·Previous participation in this clinical trial
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