Upper facial lines (horizontal forehead lines, glabellar frown lines, and lateral periorbital lines) MedDRA version: 19.1 Level: PT Classification code 10040954 Term: Skin wrinkling System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria • Signed written informed consent obtained from subject. • Outpatients (male or female) 18 years of age or older. • HFL, GFL, and symmetrical LPL of moderate to severe intensity at maximum contraction as assessed by the investigator according to the Merz Aesthetics Scales. • Stable medical condition. Eligibility criteria for reinjection • Subjects must have relapsed to at least moderate intensity at maximum contraction in all three treated areas as assessed by the investigator. • Absence of ongoing adverse events related to toxin spread. • No infection and/or inflammation in the area of the planned injection points. 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Main exclusion criteria • Previous treatment with any facial cosmetic procedure (e.g. dermal filling, chemical peeling, photo rejuvenation) in the forehead, glabellar, and/or periorbital area within the last 8 months before injection. • Previous treatment with Botulinum toxin of any serotype in the forehead, glabellar, and/or periorbital area within the last 6 months before injection. • Any previous insertion of permanent material in the forehead, glabellar, and/or periorbital area (regardless of the time between previous treatment and this study). • Planned treatment with Botulinum toxin of any serotype in the face during the study period. • Any other planned facial cosmetic procedure in the face during the study period. • Very severe lines (HFL, GFL, and/or LPL) at maximum contraction as assessed by the investigator according to the Merz Aesthetics Scales. • Inability to substantially lessen UFL (HFL, GFL, LPL) by physically spreading them apart. • Any surgery or scars in the forehead, glabellar, or periorbital area. • Marked facial asymmetry. • Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of the face. • Eyelid ptosis. • Marked brow ptosis. • History of facial nerve palsy. • Any infection and/or inflammation at the planned injection points. • Bleeding disorders or regular intake of drugs with anticoagulative effect within the last ten days prior to injection until four days after injection. • Any medical condition that may put the subject at increased risk with exposure to NT 201, including myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis or any other disorder that might interfere with neuromuscular function. • 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 BoNT A (e.g. chloroquine) within 14 days prior to injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety and tolerability of 54 to 64 Units [U] of NT 201 intramuscularly administered in subjects with moderate to severe upper facial lines [UFL] during repeat-dose treatment of these lines. ;Secondary Objective: To investigate the efficacy of simultaneous treatment of moderate to severe UFL during repeat-dose injection.;Primary end point(s): Primary safety variables: • Incidence of Treatment Emergent Adverse Events [TEAEs] during the overall period of the study. ;Timepoint(s) of evaluation of this end point: not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary safety variables: • Incidence of Treatment Emergent Adverse Events [TEAEs] per treatment cycle. • Incidence of Treatment Emergent AEs of special interest [TEAESIs] during the overall period of the study and per treatment cycle. Secondary efficacy variables: • Percentage of responders at maximum contraction for the three treated areas individually at day 30 of each injection cycle as assessed by the investigator according to the Merz Aesthetics Scales, i.e. a score of none (0) or mild (1). The periorbital region/crow’s feet will be assessed separately for each facial side (left and right) and both sides have to respond according to the previous responder definition • Percentage of responders at day 30 of each injection cycle for the overall appearance of the upper face, as self-assessed by the subject according to the Global Impression of Change Scale, i.e. a score of much improved (+2) or very much improved (+3).;Timepoint(s) of evaluation of this end point: Secondary efficacy variables at day 30 of each injection cycle | — |
Countries
Germany
Outcome results
None listed