Study with two injections (one injection with placebo or drug, one injection with drug) to investigate the efficacy and safety 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: 14.1Level: PTClassification code 10040954Term: Skin wrinklingSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2011-005887-20-DE
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
• Outpatients (male or female) 18 years of age or older.
• Calculated cut-off score below 0 in evaluation based on the Freiburg Life Quality Assessment - ‘Lebensqualität, Haut und Kosmetik’ Questionnaire [FLQA-k]).
• 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.
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 144
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
Main Period:
• Previous treatment with Botulinum toxin of any serotype in the forehead, glabellar, and/or periorbital area within the last 6 months before injection.
• Previous treatment with any facial cosmetic procedure (e.g. dermal filling,chemical peeling, photo rejuvenation) in the forehead, glabellar, and/or periorbitalarea within the last 8 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.
• Eyelid ptosis.
• Marked brow ptosis.
• History of facial nerve palsy.
• Any infection and/or inflammation at the planned injection points.
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 efficacy and safety of 54 to 64 Units of NT 201 intramuscularly administered in subjects with moderate to severe upper facial lines.;Secondary Objective: To evaluate the safety of the combined treatment;Primary end point(s): Main period only:<br>• Response at maximum contraction for the three treated areas, as assessed by the investigator according to the Merz Aesthetics Scales, i.e. a score of none (0) or mild (1). <br>• Response at maximum contraction simultaneously for all three treatment areas, as assessed by the investigator according to the Merz Aesthetics Scales, i.e. a sum score of 3 or lower.;Timepoint(s) of evaluation of this end point: Day 30
- Secondary Outcome Measures
Name Time Method