Status:
COMPLETED
Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®.
Lead Sponsor:
Merz North America, Inc.
Conditions:
Facial Wrinkles
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This was a study to find out how an investigational product, Belotero, compares to a second product in people with facial wrinkles, such as nasolabial folds. Nasolabial folds are wrinkles on the face ...
Eligibility Criteria
Inclusion
- Subjects reviewed and signed a statement of Informed Consent and a HIPAA authorization prior to initiating any study-specific procedures. In addition, subjects were asked to provide a separate release for use of their photographs in publications. Subjects could refuse the photo release without jeopardizing their eligibility to participate in the study.
- Subjects were 18 - 75 years of age, and of any race or sex.
- Female subjects were postmenopausal for at least 1 year, had a hysterectomy, or had a tubal ligation; or, if of childbearing potential, agreed to use an approved method of birth control throughout the study (i.e., oral/systemic contraceptives, intrauterine device \[IUD\], or spermicide in combination with a barrier method of contraception), were abstinent, or were in a monogamous relationship with a vasectomized partner; and had a negative urine pregnancy test at the screening visit.
- Subjects had bilateral nasolabial folds with a severity score of 2 or 3 on the wrinkle SRS assessed by the blinded evaluator.
- Each subject had an adequate understanding of the language (spoken and written English or Spanish) and was willing to comply with the study requirements.
Exclusion
- A personal history of allergic/anaphylactic reactions including hypersensitivity to local anesthetics (eg, lidocaine, etc), HA preparations, and/or gram-positive bacterial protein.
- A known history of keloids or bleeding disorders.
- An active inflammatory process in the nasolabial fold area (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, psoriasis, neurodermatitis, or any other active skin disease) or severe scarring that might interfere with study assessments.
- Women who were pregnant, planning to become pregnant during the study, or who were breast-feeding.
- Subjects who planned to undergo major facial surgery during the course of the study (eg, rhinoplasty \[with or without implant\], facelift, congenital defect repair, etc).
- Subjects with clinically important disease, as judged by the investigator, within 3 months of the study (eg, significant laboratory test abnormalities, myocardial infarct, stroke, cancer, connective tissue diseases \[scleroderma, systemic lupus erythematous\], systemic infection, uncontrolled diabetes, etc.), including those with medical conditions that might require the use of immunosuppressive medications during the trial (eg, severe, uncontrolled asthma, rheumatoid arthritis, autoimmune diseases, etc).
- Severe physical, neurological or mental disease.
- Excessive facial hair that might interfere with the evaluation of the wrinkle assessments.
- Any systemic or dermatologic disorder, which, in the opinion of the investigator,would interfere with the study results or increase the risk of adverse events (AEs).
- Subjects who had used exclusionary medications/treatments.
- Participation in a clinical investigation within the 30 days prior to the first planned device administration or during this trial.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00876265
Start Date
December 1 2006
End Date
December 1 2008
Last Update
April 26 2013
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, United States, 35205
2
Skin Care & Laser Physicians of Beverly Hills
Los Angeles, California, United States, 90069
3
Maas Clinic
San Francisco, California, United States, 94115
4
Savin Dermatology
New Haven, Connecticut, United States, 06511