Facial Wrinkles
Conditions
Keywords
Nasolabial folds
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 the face that go from outside of the nostrils to the edges of the mouth.
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 effectiveness of Belotero® in people with skin phototypes of 1(I)thru 6 (VI).
Interventions
DEVICEBelotero®
Hyaluronic acid dermal filler, Belotero®, single use syringe, injected into mid to deep dermal layer
Sponsors
Merz North America, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Was 18 to 75 years of age, of any race or sex. 3. 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. 4. Had bilateral nasolabial folds with a severity of 2 or 3 on the wrinkle severity rating scale (SRS) as assessed by the Evaluator Investigator. 5. Subjects were to have been rated IV, V, or VI on the Fitzpatrick Skin Phototype Scale. 6. Had adequate understanding of the language (spoken and written English or Spanish) and was willing to comply with the study requirements.
Exclusion criteria
1. 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. 2. A known history of keloids or bleeding disorders. 3. Leukoderma (vitiligo) or a family history of leukoderma or other pigmentary disorders. 4. 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. 5. If female, pregnant, planning to become pregnant during the study, or breast feeding. 6. Planned to undergo major facial surgery during the course of the study (eg, rhinoplasty \[with or without implant\], facelift, congenital defect repair, etc). 7. 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). 8. Severe physical, neurological or mental disease. 9. Excessive facial hair that might interfere with the evaluation of the wrinkle assessments. 10. Any systemic or dermatologic disorder, which, in the opinion of the investigator, would interfere with the study results or increase the risk of AEs. 11. Had used exclusionary medications/treatments. 12. Participation in a clinical investigation within the 30 days prior to the first planned device administration or during this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Product-related Adverse Events. | 24 weeks | Adverse events considered possibly, probably, or definitely related to study product are summarized by body system and MedDRA preferred term. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Belotero® Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects. | 93 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other | 4 |
Baseline characteristics
| Characteristic | Belotero® |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants |
| Age Continuous | 51.5 years STANDARD_DEVIATION 10.1 |
| Race/Ethnicity, Customized Hispanic or Latino | 3 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 90 participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 participants |
| Sex: Female, Male Female | 80 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 71 / 93 | 72 / 93 |
| serious Total, serious adverse events | 0 / 93 | 0 / 93 |
Outcome results
Primary
Percentage of Subjects With Product-related Adverse Events.
Adverse events considered possibly, probably, or definitely related to study product are summarized by body system and MedDRA preferred term.
Time frame: 24 weeks
Population: The Full Analysis Set (FAS) consisted of all subjects enrolled and treated with Belotero (ITT principle).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belotero, Left Nasolabial Fold | Percentage of Subjects With Product-related Adverse Events. | 71 percentage of subjects with AEs. |
| Belotero, Right Nasolabial Fold | Percentage of Subjects With Product-related Adverse Events. | 72 percentage of subjects with AEs. |