A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Extension Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects with Facial Rhytides (Crow’s Feet Lines and Glabellar Lines)
- Conditions
- Treatment of lateral canthal rhytides in the periorbital region (CFL)MedDRA version: 12.1Level: LLTClassification code 10040954Term: Skin wrinkling
- Registration Number
- EUCTR2010-021271-83-DE
- Lead Sponsor
- Allergan Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 900
1. Successful completion of Study 191622-099
2. Stable medical condition
3. Female subjects of childbearing potential must have a negative urine pregnancy test at day 1 prior to study treatment. A woman is considered NOT to be of childbearing potential if she either is postmenopausal with at least 12 consecutive months of amenorrhea or has no uterus.
4. Written informed consent has been obtained
5. Written Authorization for Use and Release of Health and Research Study Information (US sites only) and Data Protection Consent (European sites only) and/or other documentation in accordance with the relevant country and local privacy requirements has been obtained
6. Ability to follow study instructions and likely to complete all required visits
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) yes
F.1.3.1 Number of subjects for this age range
1. Any condition which precludes a subject’s ability to comply with study requirements, including completion of the study visits or inability to read, understand, and/or self-assess CFL severity using the FWS
2. Known immunization or hypersensitivity to any botulinum toxin serotype
3. Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)
4. Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
5. Known allergy or sensitivity to any of the components of the study treatments, or any materials used in the study procedures
6. Females who are pregnant, nursing, or planning a pregnancy
7. Females of childbearing potential, not using a reliable means of contraception
8. Any uncontrolled systemic disease
9. Recent history of alcohol or drug abuse based on the investigator’s judgment
10. Anticipated need for surgery or overnight hospitalization during the study
11. Subjects who plan for an extended absence away from the immediate area of the study center that would preclude them from returning for all protocol specified study visits
12. Subjects who, in the investigator’s opinion, are unable or unwilling to maintain their standardized skin care regimen throughout the study period
13. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study, with the exception of Study 191622-099
14. Subject has a condition or is in a situation which in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
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