Treatment of glabellar frown lines MedDRA version: 9.1 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 (severity score of 2 or 3 on Facial Wrinkle Scale [FWS]) as assessed by the investigator according to FWS · Completion of one study in this program (e.g. MRZ 60201-0520/1, MRZ 60201-0527/1, MRZ 60201-0724/1, or MRZ 60201-0741/1) within 45 days before Screening · Stable medical condition · Good patient compliance in previous study · Age 18 or over · Willing and able to complete at least 12 months (patients enrolled from studies MRZ 60201-0520/1, MRZ 60201-0527/1) or 6 months and up to 2 cycles (patients from studies MRZ 60201-0724/1, MRZ 60201-0741/1) of the trial and to comply with trial instructions · Written Informed Consent · Relapse to moderate or severe glabellar frown lines at maximum frown on FWS as assessed by the investigator · Lack of any condition or situation that in the investigator’s opinion may put the patient at significant risk or may interfere significantly with the patient’s participation in the trial 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 within the last 12 months in the glabellar area (except for those administered during the previous study) · Previous treatment with biodegradable fillers in the glabellar area within the last 12 months · Any previous insertion of permanent material in the glabellar area (irregardless of the time between previous treatment and this study) · Previous treatment with any facial procedure 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 aesthetic procedure in the glabellar area 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 · Concurrent use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function (e.g. D-penicillamine, 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 · Known allergy or sensitivity to the trial medication or its components · Participation in another clinical trial between completion of former study in this program and 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 · Nursing activity or pregnancy, verified by a positive pregnancy test 1, or planning of a pregnancy during the trial period · Childbearing potential with no use of an adequate birth control method (such as implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomised partner, abstinence 2 ) · Employees or direct relatives of an employee of the CROs, the study center or the sponsor · Previous participation in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Main Objective: The objective of the study is to investigate the safety and efficacy of NT 201 in repeat dose treatment for the treatment of glabellar frown lines. Subsequent cycles of treatment will be administered to the patient. As many treatment cycles as appropriate (eight at a maximum for patients from studies MRZ 60201-0527/1 and MRZ 60201-0520/1, and two at a maximum for patients from studies MRZ 60201-0724/1 and MRZ 60201-0741/1) according to the wish of the patient and the criterion for repeat dose injections assessed by the investigator may be administered until the study ends. The study will investigate endpoints of safety including immunogenicity as well as efficacy endpoints.;Primary end point(s): Safety: · Incidence of Adverse Events [AEs] · Incidence of AE of special interest [AESI] · Clinical biochemistry and hematology at Screening and at Trial Termination and at least every 12 months for completers of studies MRZ 60201-0520/1 and MRZ 60201-0527/1 · Botulinum type A antibody tests (Fluorescent Immunoassay [FIA-AB] and, if positive, subsequent Hemidiaphragma Assay [HDA]) at Screening and 30 days after treatment · Vital signs (pulse rate, blood pressure) at all visits · Physical examination at Screening and Trial Termination and at least every 12 months for completers of studies MRZ 60201-0520/1 and MRZ 60201-0527/1 · Concomitant medications at all visits · Concomitant treatments at all visits Efficacy: · Percentage of responders at maximum frown (defined as score ‘none’ or ‘mild’) at each visit as assessed by the investigator according to FWS · Percentage of responders at rest at each visit as assessed by the investigator according to FWS · Percentage of responders at maximum frown and at rest at each visit by patient’s assessment on 4-point scale · Percentage of responders at maximum frown and at rest at each visit by patient’s assessment on 6-point Likert type scale · Time to onset of treatment effect | — |
Countries
Germany
Outcome results
None listed