Status:
COMPLETED
Safety and Effectiveness of Belotero® in Subjects With Fitzpatrick Phototypes IV Through VI
Lead Sponsor:
Merz North America, Inc.
Conditions:
Facial Wrinkles
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a study to assess how safe and effective an investigational product, Belotero® is in people with all skin types with facial wrinkles, such as nasolabial folds. Nasolabial folds are wrinkles on...
Detailed Description
The Fitzpatrick Skin Phototype Scale goes from number 1 (I), which is the very lightest skin tone, to number 6 (VI) which is the very darkest skin tone. This study is to determine the safety and effec...
Eligibility Criteria
Inclusion
- Had reviewed and signed a statement of Informed Consent and HIPAA authorization. In addition, subjects were asked to provide a separate release for use of their photographs in publications. Subjects had a right to refuse the photo release without jeopardizing their eligibility to participate in the study.
- Was 18 to 75 years of age, of any race or sex.
- If female, was post-menopausal for at least one year; or had undergone a hysterectomy; or a tubal ligation; or if of childbearing potential, had negative urine pregnancy test results and agreed to use an approved method of birth control throughout the study (ie, oral/systemic contraceptives, intrauterine device \[IUD\], or spermicide in combination with a barrier method of contraception), or was abstinent, or was in a monogamous relationship with a partner who had had a vasectomy.
- Had bilateral nasolabial folds with a severity of 2 or 3 on the wrinkle severity rating scale (SRS) as assessed by the Evaluator Investigator.
- Subjects were to have been rated IV, V, or VI on the Fitzpatrick Skin Phototype Scale.
- Had 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), hyaluronic acid (HA) preparations, and/or gram-positive bacterial protein.
- A known history of keloids or bleeding disorders.
- Leukoderma (vitiligo) or a family history of leukoderma or other pigmentary 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.
- If female, pregnant, planning to become pregnant during the study, or breast feeding.
- Planned to undergo major facial surgery during the course of the study (eg, rhinoplasty \[with or without implant\], facelift, congenital defect repair, etc).
- 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 AEs.
- 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 :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00922623
Start Date
May 1 2009
End Date
July 1 2010
Last Update
April 26 2013
Active Locations (3)
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1
Pearl E Grimes
Los Angeles, California, United States, 90036
2
Valerie Callender
Mitchellville, Maryland, United States, 20721
3
Jeanine B Downie
Montclair, New Jersey, United States, 07042