Safety and Effectiveness of Belotero® in Subjects With Fitzpatrick Phototypes IV Through VI

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 effectiveness of Belotero® in people with skin phototypes of 1(I)thru 6 (VI).

Inclusion criteria

• 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 criteria

• 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.