Treatment of glabellar frown lines MedDRA version: 8.1 Level: LLT Classification code 10052609 Term: Glabellar frown lines
Conditions
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·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
Exclusion criteria
Exclusion criteria: ·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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study will consist of a Main Period and an Open-Label Extension [OLEX] Period. The Main Period has one co-primary objective comprising two primary objectives. The first of two primary objectives is to investigate the efficacy of NT 201 versus placebo in the treatment of glabellar frown lines by assessment of percentage of responders at maximum frown at Day 30 of the Main Period, as assessed by the investigator according to the Facial Wrinkle Scale [FWS]. The second of the two primary objectives is to investigate the efficacy of NT 201 by assessment of percentage of responders at Day 30 of the Main Period by patient’s global assessment of change in appearance of glabellar frown lines according to a 9-point scale.;Secondary Objective: As one secondary objective of the Main Period, the efficacy of NT 201 will be assessed by the percentage of responders at maximum frown at Days 7, 60, 90 and 120 of the Main Period by investigator’s rating according to FWS. Another secondary objective will be the percentage of responders at Days 7, 60, 90 and 120 of the Main Period by the patient’s global assessment of change in the appearance of glabellar frown lines. As one secondary objective of the OLEX Period, the percentage of responders at rest and at maximum frown on Days 7, 30, 75 and 120 of the OLEX Period by the investigator’s rating according to FWS will be investigated as well as the percentage of responders on Days 7, 30, 75 and 120 of the OLEX Period by the patient’s global assessment of change in the appearance of glabellar frown lines. ;Primary end point(s): ·Percentage of responders at maximum frown at Day 30 of Main Period, as assessed by investigator according to FWS ·Percentage of responders Day 30 of Main Period by patient’s global assessment of change in appearance of glabellar frown lines | — |
Countries
Germany
Outcome results
None listed