Open label study with up to four repeated injections to investigate the safety and efficacy of NT 201 (active ingredient: Botulinum (neuro)toxin type A, free from complexing proteins) in the combined treatment of wrinkles in the upper face.
- Conditions
- pper facial lines (horizontal forehead lines, glabellar frown lines, and lateral periorbital lines)MedDRA version: 19.1Level: PTClassification code 10040954Term: Skin wrinklingSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-003770-16-DE
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: <br>• Incidence of Treatment Emergent Adverse Events [TEAEs] during the overall period of the study. <br>;Timepoint(s) of evaluation of this end point: not applicable
- Secondary Outcome Measures
Name Time Method