Treatment of glabellar frown lines MedDRA version: 10.1 Level: LLT Classification code 10052609 Term:
Conditions
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Investigation of efficacy of NT 201 by assessing the percentage of responders at rest and at maximum frown at Days 28 and 84 by investigator’s rating according to the FWS. Evaluationv of the subject’s self assessment of the treatment success. Therefore, the percentage of responders with respect to the 4-point Patient’s Assessment Scale at rest and at maximum frown at Visit 3 (Day 28) and Visit 4 (Day 84) will be examined. A responder is defined as a subject with an improvement in the patient’s assessment of at least one point from Visit 2 (Day 0) to Visit 3 (Day 28) and Visit 4 (Day 84), respectively. Furthermore, the percentage of responders at rest and at maximum frown at Days 28 and 84 will be estimated by PGA of change in appearance of glabellar frown lines. Here, a responder has to achieve a score of at least +2 in the Patient’s Global Assessment Scale.;Primary end point(s): Response to the treatment, defined as an improvement of the FWS at maximum frown as assessed by the investigator of at least one point from Visit 2 (Day 0) to Visit 3 (Day 28). The primary efficacy parameter is the expected proportion of responders. (A parametric 95% confidence interval will be estimated for the primary efficacy parameter.) ;Main Objective: The primary objective of the study is to investigate the efficacy of NT 201 in the treatment of glabellar frown lines by assessing the proportion of responders at maximum frown at Day 28. A responder is thereby defined as a subject achieving an improvement of the FWS of at least one point from Baseline Visit to Day 28. | — |
Countries
Germany
Outcome results
None listed