Treatment of lateral periorbital wrinkles ("Crow's feet") MedDRA version: 9.1 Level: LLT Classification code 10052611 Term: Crow's feet
Conditions
Sponsors
Merz Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Moderate (grade 2) to severe (grade 3) symmetrical lateral periorbital wrinkles assessed by the investigator according to the 4-point scale - Symmetrical lateral periorbital wrinkles on both sides of the face at maximum smile - Man or woman between 18 and 60 years of age (inclusively) - Stable medical condition (precised) - 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
Exclusion criteria
Exclusion criteria: - Significant facial asymmetry - Previous facial surgery, e.g. face-lifting - Previous treatment with Botulinum toxin of any serotype in any body region 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 - 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 not using a highly effective method of birth control (defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly (such as implants, injectables, combined oral contraceptives, some intrauterine devices) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to show superiority of NT 201 treatment over placebo for both application schemes and to provide evidence that both application schemes are equally effective in subjects with moderate to severe symmetrical lateral periorbital wrinkles in terms of response. Response is hereby defined as an improvement of at least 1 point for either eye area at maximum smile at week 4 compared to baseline assessed by an independent rater using standardized digital photographs according to the 4-point scale for lateral periorbital wrinkles. A hierarchical testing procedure will be applied to show at the first level the superiority of the 3-injection regimen over placebo, at the second level superiority of the 4-injection regimen over placebo and at the third level equivalence of the two different NT 201 application schemes. ;Primary end point(s): Treatment response defined as improvement of at least 1 point on the 4-point scale for lateral periorbital wrinkles at visit 4 (week 4) for either eye area at maximum smile compared to the assessment at baseline assessed by an independent rater using standardized digital photographs. ;Secondary Objective: Analysis and comparison of: • Treatment response rate where treatment response is defined as an improvement of at least 1 point on the 4-point scale for lateral periorbital wrinkles assessed by the investigator at maximum smile at week 2, 4, 12 and 20 (Visit 3, 4, 6, 7) for either eye area compared to baseline • Improvement in appearance of lateral periorbital wrinkles for either eye area compared to baseline at week 2, 4, 12 and 20 (Visit 3, 4, 6, 7) by the subject’s global assessment. A response is defined as at least a moderate improvement, i.e. a score of at least +2 between treatment groups and application schemes. As part of the safety evaluation during the trial the incidence of adverse events, hematology, clinical biochemistry and botulinum toxin antibody values, vital signs, p | — |
Countries
France, Germany, Italy, United Kingdom
Outcome results
None listed