Nasolabial Folds
Conditions
Brief summary
A prospective, open-label 1-month post-approval study to evaluate the short term safety of Belotero® Balance in the re-treatment of nasolabial folds.
Interventions
DEVICEBelotero®
Hyaluronic acid dermal filler
Sponsors
Merz North America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Was a participant in the Belotero® Balance pre-market IDE clinical trial or the Belotero Balance Fitzpatrick Skin Type IV-VI Study. 2. Is a candidate for bilateral nasolabial fold re-treatment with Belotero® Balance. 3. Understands and accepts the obligation not to receive any other facial procedures from enrollment through 1 month from optimal correction in the current study. 4. Understands and accepts the obligation to comply with the required follow-up visits and is logistically able to meet all study requirements.
Exclusion criteria
1. Has received surgery in either nasolabial fold. 2. Has received within the past 6 months a non-permanent filler (e.g. hyaluronic acid, CaHA) or neurotoxin below the zygomatic arch. 3. Has received at any time a permanent filler (e.g. polylactic acid, PMMA, silicone) below the zygomatic arch. 4. Has received within the past 6 months dermal resurfacing procedures (e.g. medium/deep chemical peel, dermabrasion treatments, ablative laser resurfacing) or non-invasive skin-tightening (e.g. Thermage) below the zygomatic arch. 5. Has received in the past 2 weeks prescription facial wrinkle therapies (e.g., RENOVA®), topical steroids, skin irritating topical preparations, or pigmenting agents (self-tanning agents) below the zygomatic arch. 6. Has received in the past 2 months or plans to receive during the study immunosuppressive medications or systemic steroids (intranasal / inhaled steroids acceptable). 7. Has an acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events. 8. Has a known bleeding disorder or is using medication that reduces blood coagulation, (e.g. aspirin, non-steroidal anti-inflammatory drugs, or warfarin) which may increase the risk of bleeding during the treatment session. 9. Has a known history of severe allergies manifested by a history of anaphylaxis; or history or presence of multiple severe allergies. 10. Has known allergy or hypersensitivity to hyaluronic acid preparations, gram positive bacterial proteins or Belotero® or Belotero® derivative. 11. Has a known history of hyper- or hypo-pigmentation in the nasolabial folds, keloid formation, or hypertrophic scarring. 12. Is a female of childbearing potential (e.g. not post-menopausal for at least one year or has not had a hysterectomy or tubal ligation) and is pregnant, lactating or plans to become pregnant during the study or is not using medically effective birth control. 13. Has any other medical condition with the potential to interfere with the study or increase the risk of adverse events. 14. Is enrolled or plans to enroll in a competitive or interfering study. 15. Is an employee or direct relative of an employee of the investigational site or study sponsor. 16. All Fitzpatrick skin types are eligible for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Severe Common Adverse Events | 1 month | The purpose of this study was to determine if the rate of Severe common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in the Belotero® Balance IDE clinical trial and Belotero® Balance Fitzpatrick Skin Type IV-VI Study (Pre-Approval Studies).Common is defined as pre-specified adverse events occurring in \>= 5% of study subjects. These averse events are: bruising, itching, pain, redness, swelling, discoloration, nodule, and induration. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Belotero®: Hyaluronic Acid Dermal Filler Belotero®: Hyaluronic acid dermal filler | 117 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Belotero®: Hyaluronic Acid Dermal Filler |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 27 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants |
| Age, Continuous | 57.04 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment United States | 117 participants |
| Sex: Female, Male Female | 104 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 100 / 117 |
| serious Total, serious adverse events | 0 / 117 |
Outcome results
Primary
Rate of Severe Common Adverse Events
The purpose of this study was to determine if the rate of Severe common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in the Belotero® Balance IDE clinical trial and Belotero® Balance Fitzpatrick Skin Type IV-VI Study (Pre-Approval Studies).Common is defined as pre-specified adverse events occurring in \>= 5% of study subjects. These averse events are: bruising, itching, pain, redness, swelling, discoloration, nodule, and induration.
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Belotero | Rate of Severe Common Adverse Events | 8.5 percentage of 'severe' common AEs |
Comparison: The analysis was performed by comparing the proportion of subjects with severe common adverse events in the post-market study to that occurred in the pre-market studies. It was pre-specified in the protocol that the proportion of subjects with severe common adverse events in the pre-market studies was 22%.p-value: <0.02595% CI: [3.5, 13.6]One sided binomial distribution