A prospective, randomized, double-blinded, international multicenter trial to investigate the efficacy and safety of NT 201 in comparison to placebo and to compare two different application schemes of NT 201 in the treatment of lateral periorbital wrinkles - NT crow's feet
- Conditions
- Treatment of lateral periorbital wrinkles (Crow's feet)MedDRA version: 9.1 Level: LLT Classification code 10052611 Term: Crow's feet
- Registration Number
- EUCTR2006-005396-17-GB
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 108
- Moderate (severity score of 2) to severe (severity score of 3) symmetrical lateral periorbital wrinkles assessed by the investigator according to RNKLS
- Symmetrical lateral periorbital wrinkles on both sides of the face at rest and at maximum smile
- Man or woman between 18 and 60 years of age (inclusively)
- Stable medical condition
- Sum score of the evaluated questionnaire on quality of life, skin and cosmetics [FLQA-c] must be below the predefined cut-off value of 0
- Willingness of the subject to participate as documented by 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) no
F.1.3.1 Number of subjects for this age range
- Significant facial asymmetry
- Previous facial surgery, e.g. face-lifting
- Wrinkles not caused by muscular contraction
- Previous treatment with Botulinum toxin of any serotype within the last 6 months
- Previous treatment with bio-degradable fillers in the periorbital area within the last 12 months
- Any previous insertion of permanent material in the periorbital area (regardless of the time between previous treatment and this study)
- Any facial cosmetic procedure (e.g., dermal filling, chemical peeling, photo rejuvenation) in the periorbital area within the last 12 months
- Planned concomitant treatment with Botulinum toxin of any serotype in any body region during the study period
- Any other planned facial aesthetic procedure during the study period
- Inability to substantially reduce lateral periorbital wrinkles by physically spreading them apart
- Any infection in the area of the injection sites
- Any previous surgery or scars in the periorbital area
- Any medical condition that may put the subject at increased risk by exposure to NT 201 or one of the ingredients of the formulation
- Bleeding disorders
- Regular intake of drugs with anticoagulative effect (e.g., warferin, heparin, cumarines, clopidogrel) within the last 10 days
- Regular intake of vitamin E or calcium channel blockers within the last 10 days
- Concurrent use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function or that might interfere with the action of Botulinum toxin A
- Diagnosis of Lambert Eaton syndrome/myasthenia gravis, amyotrophic lateral sclerosis or any other significant neuromuscular disease that might interfere with this study
- Facial or skin conditions that in the opinion of the investigator could affect safety and/or efficacy results (e.g., acne, scars, psoriasis, allergic dermatitis, photodamage)
- History of facial nerve palsy, ptosis, weakness of periorbital muscles etc.
- Laxity of the lower lid
- If in the opinion of the investigator the subject has unrealistic expectations
- Pregnant woman, verified by a positive pregnancy test
- Nursing woman or woman of childbearing potential without reliable means of contraception (reliable contraception defined as hormonal contraception or intrauterine contraceptive device or combination of two barrier methods (e.g. condom or diaphragm plus spermicidal cream) or woman planning pregnancy during the course of the trial
- If in the opinion of the investigator the subject is unlikely to complete all study visits
- Participation in a clinical study within 30 days prior to the screening visit
- Previous randomization in this clinical study
- Other contraindications which in the investigator’s opinion preclude participation in the study
- Evidence of recent alcohol or drug abuse
- Employees or direct relatives of an employee of the CRO, the Study Center or Merz Pharmaceuticals
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method