A prospective, randomized, double-blind, 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
- lateral periorbital wrinkles (Crow's feet)MedDRA version: 6.1Level: PTClassification code 10040867
- Registration Number
- EUCTR2006-005396-17-IT
- Lead Sponsor
- MERZ PHARMACEUTICALS GMBH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 108
1.Moderate (severity score of 2) to severe (severity score of 3)symmetrical lateral periorbital wrinkles assessed by the investigator according to RNKLS
2. Symmetrical lateral periorbital wrinkles on both sides of the face
at rest and at maximum smile
3. Man or woman between 18 and 60 years of age (inclusively)
4. Stable medical condition
5. 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 2
6. 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
1.Significant facial asymmetry3
2. Previous facial surgery, e.g. face-lifting
3. Wrinkles not caused by muscular contractions
4.Previous treatment with Botulinum toxin of any serotype within
the last 6 months
5. Previous treatment with bio-degradable fillers in the periorbital
area within the last 12 months
6. Any previous insertion of permanent material in the periorbital
area (regardless of the time between previous treatment and this
study)
7.Any facial cosmetic procedure (e.g., dermal filling, chemical
peeling, photo rejuvenation) in the periorbital area within the last
12 months
8. Planned concomitant treatment with Botulinum toxin of any
serotype in any body region during the study period
9. Any other planned facial aesthetic procedure during the study period
10. Inability to substantially reduce lateral periorbital wrinkles by
physically spreading them apart
11. Any infection in the area of the injection sites
12. Any previous surgery or scars in the periorbital area
13. Any medical condition that may put the subject at increased risk by exposure to NT 201 or one of the ingredients of the formulation
14. Bleeding disorders
15. Regular intake of drugs with anticoagulative effect (e.g.,
warferin, heparin, cumarines, clopidogrel) within the last 10 days
16. Regular intake of vitamin E or calcium channel blockers within the last 10 days
17. 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
18. Diagnosis of Lambert Eaton syndrome/myasthenia gravis, amyotrophic lateral sclerosis or any other significant neuromuscular disease that might interfere with this study
19. 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)
20. History of facial nerve palsy, ptosis, weakness of periorbital muscles etc.
21. Laxity of the lower lid
22. If in the opinion of the investigator the subject has unrealistic
expectations
23. Pregnant woman, verified by a positive pregnancy test
24. 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
25. If in the opinion of the investigator the subject is unlikely to
complete all study visits.
26. Participation in a clinical study within 30 days prior to the screening visit
27. Previous randomization in this clinical study
28. Other contraindications which in the investigator?s opinion
preclude participation in the study
29. Evidence of recent alcohol or drug abuse
30. 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